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 experience in laboratory instrument qualification, ensuring compliance and quality throughout the project lifecycle.

Key Responsibilities:

  • Oversee change controls essential for project progression, ensuring adherence to compliance protocols and liaising with the Quality Assurance change control team.
  • Draft change control documentation for client evaluation and endorsement.
  • Assist in the preparation and execution of lifecycle documents.
  • Facilitate Instrument Qualification processes.
  • Prepare validation lifecycle documents for client assessment and approval.
  • Coordinate the review process for drafted documents.
  • Initiate approval workflows with Document Control.
  • Manage the routing of reviewed documents for final approval.
  • Request performance copies for validation protocols.
  • Implement approved protocols effectively.

Qualifications:

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

Ideal Candidate Attributes:

  • Self-sufficient, motivated, and results-oriented.
  • Quick to acquire new technical skills and business knowledge.
  • Possesses strong analytical and logical reasoning abilities.
  • Curious and innovative in solving complex challenges.

Benefits:

At Zifo, we pride ourselves on a culture that fosters curiosity, scientific focus, and teamwork. We are a global R&D solutions provider serving various industries, including Pharma, Biotech, and Medical Devices. Our team's scientific expertise and technological proficiency enable us to deliver exceptional service to our clients worldwide.

We emphasize the importance of scientific knowledge and professional growth, promoting an open-door policy for collaboration. Our rigorous selection process focuses on both technical skills and cultural fit.

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

Zifo is committed to diversity and is an equal opportunity employer. We value the unique contributions of every individual and 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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