Quality Control Specialist
3 weeks ago
Quality Control Analyst Role
Catalent Inc is seeking a Quality Control Analyst to execute QC testing and related analytical activities supporting product development, release and stability.
This position conducts routine and non-routine chemical and physical analyses of raw materials, in-process materials and drug products according to standard operating procedures.
The Quality Control Analyst compiles data for documentation of test procedures that may include stability program testing and formulation studies, participates in the preparation of investigations, summaries and reports, and reviews data obtained for compliance to specifications and reports out-of-trend and/or out-of-specification results.
Key Responsibilities:
- Performs analytical testing of spray dried powder using relevant methodologies (i.e. Delivered Dose, Anderson Cascade Impaction, Next Generation Impaction);
- Operates analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF);
- Statistically and critically analyzes data for trending and reporting into regulatory filings;
- Participates in Laboratory and/or Quality Investigations;
- Monitors equipment and instrumentation used on a daily basis to ensure proper operation and calibration.
- Participates in the construction and/or revision of SOPs;
- Assists in the writing and updating of analytical test procedures, protocol, log books and checklists;
- Responsible for identifying and alerting a supervisor of issues on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions;
Requirements:
- Bachelor's Degree required. Preferably in Physical or Chemical Sciences (life sciences);
- 1+ years of experience in a cGMP regulated environment highly preferred;
- Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred;
- Experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data and statistical analyses preferred;
- Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred;
- Familiarity with executing Standard Operating Procedures in a GMP setting preferred;
- Excellent oral and written communication skills required;
Why Catalent Inc?
Catalent Inc is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.
Catalent Inc is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent Inc employee.
Catalent Inc offers a diverse, inclusive culture, positive working environment focusing on continually improving processes to remain innovative, and potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
Catalent Inc is an Equal Opportunity Employer, including disability and veterans.
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