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Quality Assurance Specialist
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GQR
Waltham, MA (In Person)
$107,120 Salary, Full-Time
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Job Description
Key Responsibilities:
- Review and Approve Master Batch Production Records and Executed Batch Production Records for all programs.
- Responsible for material disposition: commercial and clinical
- Own and provide Quality assessments for change controls for clinical and commercial drug substances and drug products.
- Review and approve supplier change controls, deviations, and investigations.
- Collaborate and support internal stakeholders, along with partners on manufacturing validation and technology transfer activities.
- Collaborate and support internal stakeholders on Method validation and transfer activities.
- Review Analytical records/ Methods/ Stability reports
- Assist with the Annual Product review
- Maintain lot release and batch record review spreadsheets for quarterly metrics
- Serve as back-up QA for primary DP QA lead
- Represent QA at product team meetings (both internally and externally with our CMOs) when necessary to provide input on Quality related issues and provide updates on deliverables (such as drug product lot release or deviation closure timing)
- Maintain CofA's and disposition documentation in eQMS (Veeva)
- Assist in maintenance and continuous improvement of internal organizational procedures and processes for clinical and commercial programs.
- Support rollout of new Veeva modules, as needed.
- Revise and negotiate Quality Agreements with CMOs.
- Support authoring and review of clinical and commercial Regulatory filings.
Required Qualifications:
- B.S. degree in life sciences, chemistry or equivalent.
- 5+ years of GMP Quality experience
- Experience working with small molecule drug products.
- Ability to manage multiple projects in a dynamic environment.
- A well organized, self-motivated and independent work style with the ability to initiate and follow through on expected duties.
- Excellent interpersonal skills to assure effective interactions within and across departments, as well as with external partners.
- Experience with using risk-based principles and decision making to ensure compliance at all stages of development.
- Experience with Veeva or similar eQMS, preferred.
- Must be authorized to work in the US.