Pharmaceutical Quality Assurance Specialist

2 weeks ago

Lexington, Kentucky, United States Zifo Full time

Location: Lexington, MA – ON SITE

**This role will require the successful candidate to be on-site in Lexington, MA**

**This role is not eligible for relocation assistance**

Position Overview: Zifo is seeking a seasoned Quality Assurance Analyst with a strong background in the pharmaceutical sector. The ideal candidate will possess significant expertise in laboratory instrument qualification. This position mandates a full-time on-site presence in Lexington, MA.

Key Responsibilities:

  • Oversee change controls essential for project life cycles, ensuring adherence to process compliance while collaborating with the Quality Assurance change control team.
  • Draft change control documentation for client evaluation and endorsement.
  • Assist in the development 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 with Document Control.
  • Coordinate the routing of reviewed documents for final approval.
  • Request performance copies for protocols.
  • Execute approved protocols as per established guidelines.

Qualifications:

  • Bachelor's or Master's degree, or equivalent, in a scientific or healthcare discipline.
  • A minimum of 5 years of experience as a Validation Analyst, preferably within the pharmaceutical or life sciences industry.

Attributes of a Successful Candidate:

  • Self-sufficient, motivated, and results-oriented.
  • Quick to acquire new technical skills and business knowledge.
  • A logical thinker with strong analytical capabilities.
  • Inquisitive and innovative in solving complex challenges.

Benefits:

At Zifo, we foster a culture driven by curiosity and focused on scientific excellence. Our environment encourages debate, self-challenge, and collaboration among all team members. As a global R&D solutions provider, we cater to the pharmaceutical, biotech, manufacturing QC, medical devices, specialty chemicals, and other research-oriented sectors. Our team's scientific knowledge and technological expertise empower us to better serve our clients worldwide, including several leading biopharma companies.

We value scientific and technical proficiency while aligning with professional and personal aspirations. Our open-door policy promotes free access within the organization, while we maintain high standards for entry. Our recruitment focuses on both technical capabilities and cultural fit.

We offer a competitive compensation package that includes accrued vacation, medical, dental, vision benefits, a 401k plan with company matching, life insurance, and flexible spending accounts.

Zifo is an equal opportunity employer, committed to fostering diversity within our workforce. We do not discriminate based on race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

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