Position: QC Associate Duration: 12 months+Location: Andover - MA Job Description:
- 2-4 years of experience with word, excel, MS office, etc.
- Project management skills
- writing skills
- Multitask, cover timelines, meet timelines, etc.
- work with others
- Associates or BA
- collaborate with other team
- validate new instruments, writing protocols, data integrity, change controls
• Looking for an individual to fill a QC Associate role that will be responsible for completing Data Integrity remediation activities, performing instrument periodic reviews, assisting with instrument validation, authoring/revising SOP’s and writing investigations.
• As required, the QC Associate will also be responsible for review of microbiological laboratory data generated in support of commercial and clinical manufacturing.
• The candidate must be able to effectively manage multiple projects simultaneously. Project work will require the candidate to work with people from multiple departments.
• Potential investigation areas include: protocol deviations, cGMP testing deviations, invalid or questionable result investigations, instrument calibration Out-of-Tolerance reports, and environmental monitoring excursions.
• In addition to performing project work, the individual will be responsible for reviewing cGMP testing data generated by the QC Microbiology testing group for completeness and accuracy.
• Technical Writing role writes, or supports the development of, various technical documents such as: requirements, specifications, test plans, and user manuals. Major Role Responsibilities:
What is the minimum education experience required?
- Understands validation concepts in order to produce documentation for validated systems
- Provides evidence of compliance with legal, business and regulatory requirements
- Translates highly technical software functions/features into process driven user friendly materials to support implementation and training of applications
- Liaises with clients or developers to gather information; and Organizes, synthesizes medical and business literature, and writes clear, accurate reviews of the literature.
- Creates operational and system qualification documentation in support of Messaging Services implementation. Develops Standard Operating Procedures (SOPs), training materials, and user manuals.
- Years of Experience 2-4
- 2-4 years of experience
- Associates degree or Bachelor’s degree
- Education in Biology or Microbiology would be best, but not a must
Good Manufacturing Practices