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Pharmaceutical Quality Assurance Specialist
2 months ago
Location: Lexington, MA – ON SITE
**This position necessitates the selected candidate to be present on-site in Lexington, MA**
**This position does not qualify for relocation assistance**
Role Summary: Zifo is seeking a seasoned Quality Assurance Specialist with a background in the pharmaceutical sector. The ideal candidate will possess significant experience in laboratory instrument qualification. This role mandates a full-time on-site presence in Lexington, MA.
Key Responsibilities:
- Oversee change controls essential for project life cycles, ensuring compliance and coordination with the Quality Assurance change control sector.
- Draft change control documentation for client evaluation and endorsement.
- Assist in the preparation and execution of life cycle documents.
- Facilitate Instrument Qualification processes.
- Prepare validation life cycle documents for client assessment and approval.
- Manage the routing of drafted documents for review.
- Initiate approval workflows to Document Control.
- Coordinate the routing of reviewed documents for workflow endorsement.
- Request performance copies for protocols.
- Implement approved protocols.
Qualifications:
- Bachelor's or Master's degree or equivalent in a scientific or healthcare discipline.
- 5+ years of experience as a Technical Consultant, preferably within the pharmaceutical or life sciences sectors.
Ideal Candidate Attributes:
- Self-sufficient, motivated, and results-oriented.
- Quick to acquire new technical skills and business principles.
- A logical thinker with strong analytical abilities.
- Inquisitive and consistently seeking innovative solutions to complex challenges.
Employee Benefits:
At Zifo, we foster a culture driven by curiosity and focused on science, where collaboration and debate are encouraged. As a global R&D solutions provider, we cater to the Pharma, Biotech, Manufacturing QC, Medical Devices, specialty chemicals, and other research-centric organizations. Our team's scientific knowledge and technological expertise enable us to serve our clients effectively, including several leading Biopharma companies.
We value scientific and technical proficiency alongside professional and personal aspirations. Our open-door policy promotes accessibility, while we maintain high standards for entry. We prioritize both technical capability and cultural fit in our recruitment process.
We provide a competitive compensation package that includes accrued vacation, medical, dental, vision, 401k with company matching, life insurance, and flexible spending accounts.
Zifo is an equal opportunity employer, committed to diversity and inclusion. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.
