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.