
Pharmaceutical Quality Assurance Analyst
4 days ago
We are seeking a highly skilled and experienced Quality Control Specialist to ensure the quality of our products and processes. The successful candidate will be responsible for working closely with cross-functional teams to identify and resolve quality issues.
Key Responsibilities:- Perform cleanroom, BSC & Isolator batch related monitoring and utility sampling of water systems and Compressed Air/Gas.
- Issue, receive, and test biological indicators.
- Read and report environmental monitoring, BIs, and aseptic qualification sample results.
- Reconcile and inspect media fill units, and participate in media fills.
- Identify Microorganisms isolated post testing activities and complete all laboratory documentation in a timely and accurate manner.
- Ensure compliance with Standard Operating Procedures and Registered Specifications.
- Assist in authoring and reviewing documentation and review paperwork.
- The ideal candidate should hold a minimum of a Level 8 degree in Microbiology or a related discipline.
- Strong experience in a pharmaceutical / healthcare laboratory or a related technical function is essential.
- The candidate should have relevant experience working in a cleanroom environment using aseptic techniques and experience working with isolators is advantageous.
- Experience in HPLC and UV Spectrophotometry is desirable but not essential.
- Experience using MODA, Empower, CIMS, LIMS, LES and Veeva Vault is also desirable but not essential.
- The successful candidate must demonstrate excellent written and verbal communication skills.
- Ability to work in a team-based collaborative environment is crucial.
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