Data Reviewer, QC
23 days ago
Pennington
Essential Functions of the job: • Review and validate QC data and test records., • Support investigations related to Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) results., • Ensure compliance with current Good Manufacturing Practices (cGMP) in the laboratory., • Assist in the technical documentation of investigations and change control assessments to evaluate the impact on product quality, in alignment with FDA/EU regulations, international standards, • Undertake other duties as required. This position is ideal for candidates who are detail-oriented and committed to quality assurance in the pharmaceutical industry. Education/Experience Required: • Bachelor’s Degree or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline. Scientific degree (ideally chemistry, biochemistry, biotechnology or related)., • Minimum 4 years working experience in an FDA-regulated biotechnology or pharmaceutical company is required., • Working knowledge and experience with chemistry analytical methods such as HPLC, GC, TOC, Capillary Electrophoresis (CGE-Reduced, CGE-Non-Reduced, and Capillary Zone Electrophoresis), etc., • Strong working knowledge with USP/EP and cGMP/EU GMP., • Technical writing experience., • Familiar with instrument and equipment validation., • Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level., • Credible and confident communicator (written and verbal) at all levels., • Strong analytical and problem-solving ability., • Hands-on approach, with a ‘can do’ attitude., • Ability to prioritize, demonstrating good time management skills., • Excellent attention to detail, with the ability to work accurately in a busy and demanding environment., • Self-motivated, with the ability to work proactively using own initiative., • Committed to learning and development, • Self-motivated, with the ability to work proactively using own initiative. Computer Skills: • Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). Travel: • Must be willing to travel approximately 10%., • Ability to work on a computer for extended periods of time.