Quality Control Analyst II
1 month ago
Catalent is a global leader in the development and manufacturing of new treatments for patients worldwide. We are seeking a Quality Control Analyst II to join our team in Boston, Massachusetts.
Job SummaryThe Quality Control Analyst II will be responsible for executing QC testing and related analytical activities supporting product development, release, and stability. This includes conducting routine and non-routine chemical and physical analyses of raw materials, in-process materials, and drug products according to standard operating procedures.
Key Responsibilities- Perform analytical testing of spray dried powder using relevant methodologies (i.e. Delivered Dose, Anderson Cascade Impaction, Next Generation Impaction)
- Operate analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF)
- Statistically and critically analyze data for trending and reporting into regulatory filings
- Participate in Laboratory and/or Quality Investigations
- Monitor equipment and instrumentation used on a daily basis to ensure proper operation and calibration
- Participate in the construction and/or revision of SOPs
- Assist 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
- Bachelor's Degree required. Preferably in Physical or Chemical Sciences (life sciences) with a minimum of 2+ years of relevant work experience required
- 1+ years regulated GMP environment experience required
- Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred
- Extensive experience with executing QC test methods, generating associated data packages, auditing data packages generated by others, troubleshooting instrumentation, trending data, and statistical analyses required
- Demonstrated ability to lead and/or author investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required
- Ability to troubleshoot and repair analytical instrumentation such as HPLCs and UPLCs preferred
- Experience with analytical method development and validation preferred
- Defined career path and annual performance review and feedback process
- Diverse, inclusive culture
- Positive working environment focusing on continually improving processes to remain innovative
- Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
- 152 Hours + 8 paid holidays
- Several Employee Resource Groups focusing on D&I
- Dynamic, fast-paced work environment
- Community engagement and green initiatives
- Generous 401K match
- Company match on donations to organizations
- Medical, dental, and vision benefits effective day one of employment
- Tuition Reimbursement – Let us help you finish your degree or start a new degree
- WellHub program to promote overall physical wellness
- Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories
Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
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