News

General Information:

Company: Colorado Dept of Transportation, Denver, CO

• Hiring: Process Improvement Interns (Fall 2014 term)
• CLASS TITLE: LTC Ops II
• SALARY Range: $15.62/hr
• LOCATION: 4201 E. Arkansas Ave. Denver, C0 80222
• Applicagtion OPENING DATE: 6/12/14 to CLOSING DATE: 7/20/2014
• This position is part-time to accommodate student schedules.
• This is a paid temporary position with no benefits and will exist for 9 months or less.
• Appointment may be made as early as July 1, 2014.

OVERVIEW OF JOB

The purpose of this collegiate internship is to provide meaningful professional process improvement experience to collegiate students with proven academic performance and a strong desire to learn and contribute.

The Office of Process Improvement provides the infrastructure, procedures, processes, training, and support which facilitate and promote a culture of continuous improvement at CDOT.

DUTIES include the following but not limited to:

• Assisting CDOT process improvement projects with:

• Characterizing and documenting basic process and operating information;
• Assessing the effectiveness and efficiency of processes (including the use of continuous improvement methodologies);
• Developing recommendations for improving operations;

• Providing a summary presentation at the conclusion of the internship regarding the internship experience;
• Assist instructors who provide training in process improvement methods, tools, and techniques; and
• Perform other duties as assigned.

This position is located on CDOT’s Headquarters Campus, 4201 E. Arkansas Avenue in Denver, Colorado.

Additional information about the process improvement internship experience is available at:

http://www.coloradodot.info/business/process-improvement/internship-opportunities-in-process-improvement

Education and Experience Requirements:

• Qualified candidates must be enrolled as an undergraduate or graduate student at an accredited college or university, college, or similar learning institution, with at least a 3.0 cumulative GPA during the last completed semester/quarter.
• Please note: if you were enrolled during the Spring term of 2014, and will continue enrollment during Fall term of 2014, you may apply on this position.
• A copy of your transcripts must be attached to this application.
• The Exceptional Candidate will be an undergraduate college/university student interested in applying process improvement techniques in an organization and has proven accomplishments in the following:
• Completion of 3 years or more in an accredited university in a process improvement curriculum or a discipline related to process improvement (such as industrial engineering, systems engineering, quality assurance, business management, operations research, or management science).
• Knowledge and experience with continuous improvement technologies such as Total Quality Management (TQM), Theory of Constraints, Operational Excellence, Lean Enterprise, or Six Sigma.
• Knowledge and experience with documenting processes and operations.
• Knowledge of change management (the people side of change).
• Excellent interpersonal skills
• Excellent verbal and written communication skills.
• Ability to perform duties with minimal supervision.
• Familiarity with the Microsoft Office suite (including Visio), and Microsoft Outlook; experience with Microsoft SharePoint knowledge a plus.

To Apply on-line:

Go to www.colorado.gov/cojobs and view the announcement under Department of Transportation.

Application Checklist – A completed application must include:

• Attach a cover letter explaining your qualifications and interest in this position.
• Attach a current copy of your college / university transcripts in the “Attachment ” section of this application.
• Attach a chronological resume to the “Attachment” section of this application.

For more information contact:

• Joe Czajka, Workforce Staffing Manager
• phone: 303.757.9150 email: Joseph.czajka@state.co.us

 General Information:

Sartorius  is looking for Quality Associate in Arvada CO

Reports to: Quality Manager

Position Summary:

• At the Arvada site, administer and oversee the requirements defined by the North America quality management system to ensure that products manufactured at the site consistently meet performance and quality specifications.
• Additionally ensure that all processes related to the distribution of products meet local and global policy requirements.
• Assist as needed to ensure that the North American quality management system is properly managed and maintained.

Essential Duties and Responsibilities:

• Ensure that the Arvada site complies with established quality requirements for ISO 9001 and GMP’s for the controlled distribution of products including medical devices
• Perform incoming inspection of all raw materials and components used for manufacturing
• Release finished products for distribution
• Perform any required CAPA or Deviation investigations
• Assist Process Engineer with the investigation of any customer, vendor, and internal quality issues or complaints
• Create, review and sign off any related documents or records
• Ensure applicable equipment used in manufacturing is properly calibrated, and preventive maintenance schedules and activities are maintained
• Perform quality check of all products received for distribution and required inspections of all returned products
• Ensure that returned products requiring complaint investigation are dispatched to the proper quality group
• Ensure that any quarantined products are controlled properly and cannot be used in manufacturing or placed into distribution
• Perform internal audits for compliance to the quality management system
• Assist site management team as needed to meet site quality goals and objectives
• Assist North American Corporate Quality with the collection of data for the management review
• Perform vendor quality system audits for North American vendors
• Perform site registration with FDA for importer distributor of medical devices
• Keep track of all data related to the handling or distribution of medical devices in North America
• Assist Corporate Quality in New York as needed regarding North American quality issues
• Assist in hosting third party audits in Arvada

Qualifications and Requirements:

• BS in any Quality/Engineering/Science discipline with 3-5 years’ experience, or AS in any Quality/Engineering/Science discipline with 5-7 years’ experience
• Knowledge of manufacturing and distribution
• Knowledge of ISO-9001, and current FDA Good Manufacturing Practices
• Understanding of quality systems methods
• Experience in internal auditing and vendor auditing
• Problem-solving and analytical skills
• Good verbal and written communication skills
• Ability to work independently and in a team environment
• Able to interact with all levels inside and outside the organization
• Some physical work required – must be able to lift 50-lbs
• Strong Microsoft Office skills
• Traveling is expected, ~15%

Additional Comments:

• All qualified applicants will receive consideration for employment without regard to race, creed, color, or national origin.

If you are interested in this opportunity, please apply online at http://www.sartorius.us/us/company/careers/vacancies/job/show/8349

General Information:

Pro QC International is looking for contract QC inspectors and/or auditors in the Boulder-Denver Colorado Metro Area

• Pro QC is an international third party quality consulting and engineering firm.
• Our services include but are not limited to quality inspections, product testing, corrective action, and supplier audits (TS16949, SA8000, ISO9001, QS9000, etc).
• Learn more about us at  http://www.proqcna.com/

Job Information

• Pro QC is currently seeking contracted quality assurance inspectors and auditors to assist with projects across the USA, Canada and Mexico.
• Pro QC has Boulder CO and Denver CO offices
• Inspections generally include quantity verification and random sampling for visual/workmanship evaluation, functional testing, and packaging integrity verification.
• Sampling employed follows ANSI Z1.4 specifications (MIL105E).
• Interested candidates should be comfortable providing electronic reports and should have a digital camera.
• Reports are in a MS Word format.

Additional Information:

• Contract Projects Only (1099)
• BS in Mechanical or Industrial Engineering or CQE/CQI preferred.
• ASQ, ISO, RABQSA or credentials from similar body along with industry experience are also preferred.
• Additional Salary Information: 1099 Hourly + IRS Mileage

More information and to apply with Resume and cover letter

• Contact Jennifer Stepniowski via phone: +1 813 428-3277
•  or email: jenn@proqcna.com  with subject: “Pro QC: Contract QC position in Boulder-Denver CO”
• Also see PRO QC careers web page http://proqc.com/about/careers

 General Information:

• Job Title: Senior Quality Assurance Associate
• Company:  Corgenix Inc, Broomfield, CO
• Department: Quality and Regulatory Affairs
• Reports to: Director, Quality and Regulatory Affairs
• GENERAL PURPOSE: Oversees Quality Assurance activities to ensure compliance with regulatory agencies, ISO, and Corgenix requirements.

KEY RESPONSIBILITIES:

• Final disposition authority for incoming materials, including packaging and labeling, used in product manufacturing.
• Manage the Approved Vendor List and vendor system, perform supplier audits.
• Review and final approval authority for device history records.
• Develop quality assurance policies, procedures, instructions, and records in accordance with current regulatory requirements. Present and activate such policies, as approved by management.
• Assist in establishing document approval and change control procedures. Assist with document control procedures, as necessary.
• Assist personnel in developing procedures, instructions, test methods, and records, as requested.
• Assist the Director of Quality and Regulatory Affairs in scheduling, initiating, and performing departmental audits of systems and processes.
• Final review and approval signature on validation studies.
• Responsible for employee quality system training in accordance with regulatory requirements (QSR and ISO). This includes presenting initial QSR training for all new employees and developing annual company update training for all employees. Furthermore, this position is responsible for designing and assisting in all Quality Assurance related training.
• Manage CAPA program to ensure timely completion of each CAPA phase and ensure the effectiveness of CAPAs.
• Oversee coordination and maintenance of company quality training program files.
• Final review and sign off approval for new documents/new document revisions prior to distribution.
• Assist in FDA and ISO inspections, follow-up actions, and correspondence regarding compliance issues.
• Assist the Director of Quality and Regulatory Affairs in the development and execution of Quality Department operational and strategic programs including work plans, short and long range goals, audit requirements, training needs, and budgets.
• Manage filing and database inputs of quality documents (e.g. process validations, equipment validations, Action Impact Reviews, packaging and transport testing).
• Contribute to Quality Forum newsletters, conduct training, and perform other activities to educate employees on quality concepts.
• Final review and sign off of final product.
• Other duties as assigned by Supervisor.

CONTACTS

• INSIDE COMPANY: Works closely with Quality Control, Document Control, Manufacturing, Marketing, Regulatory Affairs, and R&D.
• OUTSIDE COMPANY: Raw material suppliers concerning quality and compliance issues. FDA and ISO regarding compliance issues.

JOB TITLE DIRECTLY SUPERVISED: N/A

WORKING CONDITIONS

• This position primarily functions in a typical office environment.
• Due to the interaction with Quality Control, this position will occasionally function in a laboratory setting with risk of exposure to biological and chemical hazards associated with such a setting.
• The position requires a moderate level of mental exertion, with the individual having to respond to short deadlines and crises.
• The position may require in excess of forty hours per week and generate a moderate amount of stress.

SPECIALIZED EQUIPMENT USED:

• General office equipment including personal computer hardware, standard computer software (e.g., word processing, spread sheets, database, statistical programs), copiers, Fax machines, paper shredder, paper binding equipment, and printers.

ACCOUNTABILITY/SCOPE OF THE POSITION:

• This position is accountable for the Quality Assurance activities of the company.
• It is a highly visible position, integral to the Company’s short and long term success.
• This position is key to the long and short term success of the company and requires a high level of commitment to the goals set by the Quality and Regulatory Affairs Department and the company.

BACKGROUND KNOWLEDGE:

• A Bachelors Degree is required along with a working knowledge of Quality Assurance principles and methods.

EXPERIENCE:

• This position requires a minimum of 6 years working experience in a Quality Assurance role within an FDA regulated environment (Medical Device industry preferred).
• Knowledge of the FDA Quality System Regulation and ISO13485 is strongly preferred.

GENERAL:

• This person must demonstrate the ability to work and think independently and possess excellent written and oral communication skills.
• Qualified candidates should send resume and cover letter to dfsimpson@corgenix.com

General Information:

University of Colorado’s School of Medicine

Position: Director of Quality

About the Company:

The Gates Biomanufacturing Facility will be established as an auxiliary service center of the University of Colorado’s School of Medicine, Department of Dermatology and the Charles C. Gates Center for Regenerative Medicine and Stem Cell Biology

Job Description:

• The Gates Biomanufacturing Facility is seeking a qualified candidate that will be responsible for directing quality assurance and quality control (QA/QC) for the Facility.
• The Director of Quality will plan and establish QA/QC policies, programs, systems and initiatives.
• In addition, the selected candidate will establish testing methods and systems to ensure quality standards and specifications are met.

Requirements:

• Examples of Work Performed
  • Design, establish, and manage QA/QC policies, programs and systems.
  • Review and approval of all products and materials for release.
  • Participate in the preparation of CMC section for a biological product IND.
  • Establish positive relationships with internal and external members of the Gates Center community as well as users of the manufacturing facility.
• Knowledge, Skills, and Abilities
  • Master’s Degree or equivalent experience in a life sciences discipline.
  • Significant industrial experience in QA/QC.
  • Strong knowledge of cGMP/cGTP regulations and industry standards.
  • Familiar with the preparation and development of CMC section for a biological product IND.
  • Experience with working in a biotech startup environment.
  • A team-oriented, self-starter capable of operating independently.
  • Effective interpersonal communication skills.
• Minimum Requirements
  • Master’s Degree or equivalent experience in a life sciences discipline.
  • At least 10 years of industrial biotech experience in a QA/QC role.
  • A team-oriented, self-starter capable of operating independently.
• Preferred Qualifications
  • Experience working for biotech companies is a plus.
  • Experience working in a cGMP manufacturing setting is desired.
• Application Information:
  • All applications must be submitted electronically at www.jobsatcu.com, refer to job posting RF01234.
  • The jobsatcu.com employment board has this position listed as a Research Instructor.

Required Application Materials:

• When applying at www.jobsatcu.com, applicants must include:
  • A letter of application which specifically addresses the job requirements and outlines qualifications.
  • A current CV/Resume.
  • The names, addresses, daytime telephone numbers and e-mail addresses for three professional references.

More information

• Review of applications will continue until the position is filled.
• Salary is commensurate with skills and experience.
• The University of Colorado offers a full benefits package.
• Information on University benefits programs, including eligibility, is located at http://www.cu.edu/pbs/
• Please be advised that the University does check references as part of the employment process.

 

General Information:

• Company: Terumo BCT
• JOB TITLE: Sr. Regulatory Affairs Specialist
• Job Requisition: JB-1970
• Working without significant direction, provides leadership to the Company in fulfilling regulatory compliance by applying a thorough understanding of regulatory/standards requirements to one or more areas of expertise such as FDA regulations, international medical device regulations, product reimbursement, product liability, and standards.

ESSENTIAL DUTIES

• Assumes major responsibility for one or more major regulatory affairs areas based on past experience and a broad base of knowledge and understanding of regulatory requirements.
• Interacts with and/or directs others in interacting with regulatory and certification authorities. Identifies the need for, prepares, and conducts regulatory related training for the business.
• Identifies and defines contents for regulatory submissions/dossiers. Leads the assembly and creation of these documents for their timely submission to regulatory authorities.
• Advises business management of regulatory and certification issues in a pro-active manner.
• Exercises considerable judgment in determining approach and then researches, prepares, and submits required regulatory documents including those in response to documents issued by regulatory authorities. Responsibility includes both preparation of these documents in compliance with U.S. and international regulatory authorities and providing guidance to Regulatory staff in the preparation of them.
• Provides regulatory support of clinical trials.

MINIMUM QUALIFICATION REQUIREMENTS

• Education: Bachelor’s degree or, equivalent of education and experience sufficient to successfully perform the essential functions of the job may be considered.
• Experience: Minimum 5 years experience.
• Skills
  • Pharmaceutical, or medical device regulatory experience desired.
  • Familiarity with developing IDE, IND, NDA, ANDA 510(k) or PMA US FDA applications desired.
  • Experience with design control systems and project team experience a plus.
  • Knowledge and use of relevant PC software applications and skills to use them effectively.
  • Demonstrated ability to communicate effectively both verbally and in writing.
  • In depth knowledge of U.S. and/or international medical device regulations and standards.
  • Extensive knowledge of and ability to prepare regulatory documentation.
  • Proven effective leadership and team skills. Strong interpersonal skills.
  • Demonstrated ability to define problems and provide guidance to management in developing and implementing solutions.
  • Analytical and creative thinking skills and the ability to solve complex problems.
  • -Or- An equivalent competency level acquired through a variation of these qualifications may be considered.

PHYSICAL REQUIREMENTS

• Typical Office Environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, and occasional lifting up to 20 pounds.
• The physical demands described here are representative of those that must be met by an associate to successfully perform the essential duties of this job.
• Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties.

EEOC and drug-free workplace:

• We are proud to be an Equal Opportunity Affirmative Action Employer.
• All applicants will be afforded equal opportunity without discrimination because of race, color, religion, sex, sexual orientation, marital status, order of protection status, national origin or ancestry, citizenship status, age, physical or mental disability unrelated to ability, military status or an unfavorable discharge from military service.
• We maintain a drug-free workplace and perform pre-employment substance abuse testing and background verification checks.

Apply and More information

• For more information about Terumo BCT and to apply, visit our careers website http://www.terumobct.com/careers.
• Go to the careers section and apply to requisition JB-1970

General Information:

• Company: Rocky Mountain Eye Bank http://www.corneas.org
• JOB TITLE: Quality Assurance Coordinator
• JOB CLASSIFICATION: Full-time, non-exempt
• LOCATION OF POSITION: Aurora Office
• THIS POSITION REPORTS TO: Quality Assurance Manager
• SUMMARY STATEMENT:
  • The Quality Assurance Coordinator assures compliance with government and industry standards.
  • The Quality Assurance Coordinator monitors SOP/document forms, change control process, champions a continuous quality improvement process and may be the Eye Bank’s OSHA representative.

ASSIGNED RESPONSIBILITIES AND DUTIES:

• Receiving and investigating departures, deviations and corrective actions
• Follow-up and tracking corrective action effectiveness
• As needed assist with SOP/document change control process
• Assist with records retention control
• Monitor equipment verification, maintenance, and cleaning records
• Perform activities associated with inspections, audits, monitoring, and trending
• Review / audit records and procedures for completeness, accuracy, and compliance
• Activities associated with vendors and contracted service providers – agreements, off site audits
• Review donor records for completeness, accuracy and data collection after distribution
• Perform customer service tasks with current and potential surgeons
• Assist with or conduct new surgeon orientation
• Receive, investigate and evaluate information to include complaints and donor new information
• Assist in managing adverse reactions/events and complaint trends
• Follow-up and data entry of pending recipient information for transplanted tissues, including Recipient Information Forms and Recipient Post-operative Follow-up Forms
• Provide feedback and training to technical staff related to chart completeness and accuracy
• Provide new employee safety training
• Assess organizational training needs as part of a team; design, coordinate and implement training programs
• Assist in compiling, disseminating, and examining statistical data as directed
• Complete Department of Health Serology Reporting.
• Perform other duties as necessary and as assigned by management

QUALIFICATION REQUIREMENTS:

• EDUCATION:
  • A Bachelor’s degree in a science related field is required.
  • Appropriate regulated industry experience or certification may be substituted for education.
  • Thorough knowledge of ocular anatomy and physiology as well as medical and medical terminology knowledge is needed to understand aspects of eye banking.
• EXPERIENCE:
  • The Quality Assurance Coordinator should have at least 2 years experience working in a regulated industry.
  • Knowledge and experience with FDA regulations and quality systems (cGTP or cGMP) is a must.
  • An understanding of auditing practices and basic statistical analysis is needed.
  • Familiarity with EBAA or AATB medical standards is a plus.
  • The Coordinator should have experience working with quality systems / programs, preferably in eye or tissue banking, medical diagnostics, medical devices or other medical areas.
  • Consideration will be given to candidates with equivalent experience or knowledge from a cross-over profession or industry.
  • The Coordinator should be familiar with MS Office, donor databases and electronic quality databases.
  • The Coordinator is responsible for performing administrative aspects that may include interaction with or within the Technical, Quality, Public Relations and Accounting Departments.
  • The position requires excellent people skills, as well as effective written and verbal skills for both internal and external communication.
  • The Coordinator may be asked to develop and maintain business relationships with surgeons, surgery sites and their staff in an effort to open communication channels for reliable quality monitoring.
  • The specific training is provided by the managers of each department where applicable.

COMPENSATION:

• Salary Range is dependent upon experience.
• RMEB provides a full benefits package to include healthcare, dental, vision, 401k, holidays, paid time off and flexible scheduling.

Apply and More information

• Resumes must be accompanied by a cover letter explaining how the applicant meets the job requirements and desired skills.
• Please email cover letter and resumes to mailto:swolff@corneas.org with applicant name and the job title listing in the subject line.
• note: The deadline for application submission is April 29, 2014.
• No phone calls, please.

General Information:

• Name: DAVID SERTL, M.S., RAC, CQA
• Phone:: +1 303-438-8950
• E-Mail: dsertl08@cs.com
• Linkedin: http://www.linkedin.com/in/davesertl
• ASQ Boulder Section on-line Resume David Sertl.pdf (Update Apr 2014)

Quality Scientist

• A versatile scientist with a unique understanding of both analytical chemistry and regulatory affairs and their relationship to the quality of FDA-regulated products.
• Utilizing critical thinking, networking and organizational skills to solve problems and move projects forward to successful completion.
• Innovating to optimize processes and drive improvements in the quality of regulated products.
• Contributing to inter-departmental teams resulting in the successful development and commercialization of new products generating sales of >$200M/year in an FDA-regulated industry.
• Skills Include: Quality & Investigations; Root Cause, OOS, CAPA; Critical Thinking; Regulatory Compliance; cGMP Requirements; Technical Review;