Quality Control Analyst IV

Catalent Pharma Solutions; Chelsea (MA); On-site; USD 60,000 - 100,000; Full time

Job summary

Join a forward-thinking company as a Quality Control Analyst IV, where you will play a pivotal role in ensuring the quality of life-saving products. This dynamic position involves operating advanced analytical instrumentation and leading investigations in a cGMP laboratory setting. You will mentor team members while contributing to a culture of continuous improvement and innovation. With a commitment to professional growth and a supportive environment, this role offers an exciting opportunity to make a meaningful impact in the pharmaceutical industry. Be part of a team dedicated to enhancing lives through quality and excellence.

Benefits

Defined career path

Diverse, inclusive culture

Positive working environment

Generous 401K match

Medical, dental and vision benefits

Tuition Reimbursement

WellHub program

Community engagement initiatives

Employee Resource Groups

Exclusive discounts from merchants

Qualifications

• 5+ years of experience in a cGMP regulated environment required.
• Demonstrated ability to lead investigations for OOTs and OOSs.

Responsibilities

• Operates analytical instrumentation for GMP testing of materials and products.
• Leads investigations for deviations and product quality complaints.

Skills

Chromatography

Statistical Analysis

Analytical Instrumentation

GMP QC Testing

Troubleshooting

Education

Bachelor's Degree in Physical or Chemical Sciences

Tools

HPLC

UPLC

GC

UV-vis

FTIR

Job description

Quality Control Analyst IV

Position Summary:

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

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. On-site spray dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America.

Catalent Pharma Solutions is hiring a Quality Control Analyst IV who is a key analytical leader in a cGMP laboratory capable of both clinical development and commercial testing. This analyst is both a mentor and trainer to team members and serves as a backup to QC management.

This is a full time, salaried role, Monday – Friday 8:00AM – 4:30PM

The Role

• Operates analytical instrumentation (i.e. HPLC, UPLC, GC, UV-vis, FTIR, laser diffraction, KF, etc) for GMP testing of materials and product, for method transfers/validation, and for investigational purposes in a compliant and efficient manner;
• Performs data review and reporting (CofAs, reports, etc);
• Statistically and critically analyzes data for trending and reporting in quarterly quality reviews and annual product reviews;
• Leads investigations for Deviations, OOS/OOT results, and Product Quality Complaints;
• Monitors equipment and instrumentation to ensure efficient laboratory operations;
• Authors/Reviews/Approves controlled documents such as SOPs, analytical test procedures, protocols, logbooks and checklists;
• Identifies and escalates both issues and opportunities for efficiencies on instruments and/or test executions; makes initial recommendations for possible solutions and/or corrective actions and implements solutions as appropriate;
• Trains and mentors team members on analytical instrumentation and material/product test methods;
• Leads team standup meetings and assists in laboratory scheduling;
• All other duties as assigned

The Candidate

• Bachelor’s Degree in Physical or Chemical Sciences (life sciences) required;
• Minimum of five (5) years of experience in a cGMP regulated environment required;
• Experience in MDI/DPI analytical test methods (i.e. Andersen Cascade Impactor and Emitted Dose techniques) preferred;
• Extensive experience with executing GMP 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;
• Chromatography skills using Empower and/or ChemStation required;
• Critical understanding of the importance of documentation and data traceability required;
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• 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 offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

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, and confirming your request for an accommodation and include the job number, title and location to [e-mail]. This option is reserved for individuals who require accommodation due to a disability.