Pharmaceutical Quality Assurance Specialist

3 days ago


Chelsea, Massachusetts, United States Disability Solutions Full time

Catalent is a leading global pharmaceutical company that specializes in the development and manufacturing of new treatments for patients worldwide.

The Boston-area facility is Catalent's global Center of Excellence for spray dry dispersion and Dry Powder Inhaler (DPI) capsule manufacture and packaging. The site features inhaled powder spray drying, as well as multiple commercial-scale lines for capsule filling and blister packaging.

We are seeking a Quality Control Analyst who will be responsible for executing QC testing and related analytical activities supporting product development, release and stability. This person conducts routine and non-routine chemical and physical analyses of raw materials, in-process materials and drug products according to standard operating procedures.

The salary for this position is estimated at $65,000 per year, based on industry standards and the location of the job.

Required skills and qualifications include:

  • 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;

Benefits include defined career path, 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, WellHub program to promote overall physical wellness, Perkspot offering exclusive private discounts from approximately 900 merchants in a wide array of categories.



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