Data Reviewer, QC

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 standardsUndertake 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 developmentSelf-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.