Quality Control Analyst III Job Responsibilities
Education & Qualifications
- Act as study director for validation of analytical methods and lab equipment
- Author validation protocols / reports, test methods and records
- Contribute scientific knowledge, analytical skills, and interpretation of data
- Ensure a consistent style of QCRM documents to maintain quality and ease of review
- Support analytical SOP method optimization, validation, transfer, and life cycle management
- Support Out-of-Specification Investigations, CAPA events and Change Controls.
- Support readiness for regulatory inspections and compliance audits.
- Assess routine compendial updates for impact to existing testing procedures
- Support development of junior analysts through mentoring
- Practice safe work habits and adhere to the company's safety procedures and guidelines
- Maintain proficiency training per assigned curricula
An ideal candidate will have extensive analytical lab experience that can translate to method / instrument validation and document authoring. Emphasis will be placed on past analytical experience, with technical writing experience being a slightly lower position requirement.
- Bachelor's degree in a related discipline
- Minimum of 5 years of experience in cGMP laboratory environment
- Hands-on experience with a broad range of lab equipment:
- First-hand experience with compendial analysis of raw materials:
- Previous experience performing cGMP analytical analyses.
- Strong verbal and written skills
- Previous experience with lab control operations and quality systems
- Preferred experience with chromatography data systems (Empower)
- E.g. - FTIR, UV, UPLC-MS, GC, pH, KF, Autotitrator, ICP-MS,
- E.g. - Salts, acids, bases, resins
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.