Quality Assurance Associate
Location: Englewood, CO
Name: Cynthia Silva
Quality Assurance Supplier Manager 45K-90K
This position will report to the Quality Manager. The Quality Specialist evaluates, tracks, trends, and monitors the Quality Assurance activities in an outsourcing facility. The position is responsible for corporate supplier quality to ensure that all critical supply vendors have been approved either through paper or onsite audits depending on vendor criticality. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance, attention to detail, and excellent communication with other functional areas and sites. Moreover, the role is responsible for promoting our mission of improving patient outcomes with high quality outsourced pharmaceuticals.
• Evaluating, selecting and monitoring supplier performance.
• Ensuring suppliers are maintained in good status.
• Perform onsite audits of all tier 1 (product contacting) critical suppliers to ensure the suppliers meets Leiters Quality requirements.
• Maintain and perform supplier assessments of Tier 1, 2, 3, 4 vendors.
• Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately, and acceptance criteria met.
• Draft, review or approve sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures.
• Evaluate and write validation protocols including commercial batch and stability test methods as well as sterilization techniques for consumables, containers and finished drug products. Also, provide support to equipment validation and subsequent quality dispositioning.
• Review and approve criteria for analyses carried out under contract through private labs. Ensure that the appropriate validations, including those of analytical procedures, and calibration of control equipment are performed.
• Review and approve maintenance activities for processes and equipment.
• Ensure that the required initial and continuing training of personnel is carried out and adapted according to need
• Review and approve investigations of reprocessing/rework of products, complaints, analytical failures, and returns/salvages
• Classify, file, audit, receive, distribute, track and maintain system of classified and unclassified company documents according to established procedures and standards for security and document organization.
• Supporting or performing internal audits.
• Supporting external regulatory or customer audits.
• Gather information from multiple departments for trending and presentation to management.
• Identify trends in the industry and recommend improvements
• Work with a team to ensure that the systems involved in an outsourcing facility are in a state of control
• Other duties as assigned to ensure appropriate quality practices
EXPERIENCE AND NECESSARY SKILLS:
• Knowledge and experience with the cGMPs, preferably in a commercial compounding outsource facility
• Able to identify potential adverse issues
• Excellent organization and documentation skills
• Detail oriented
• Computer skills, including Microsoft Word and Excel
• BS or BA degree (in a scientific discipline desired
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—
providing you with opportunities to work on today’s most challenging, research-intensive, and relevant
projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help
advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000
scientific professionals last year.
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Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,
Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
is The Law.