Analytical Quality Associate III

Analytical Quality Associate III

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 Research Triangle Park (RTP) facility is home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays. 

Catalent Pharma Solutions is Morrisville, NC is hiring an Analytical Quality Associate III who is responsible to independently audit analytical projects for adherence to procedures and regulations related to pharmaceuticals. Comply with divisional and site Environmental Health and Safety requirements.

This is a full-time salaried role.  This is an onsite position, no remote/hybrid available. The core hours are Monday – Friday 8:00AM – 5:00PM.  

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee. 

The Role:

• Performs laboratory compliance audits, project archival and pack-outs;  
• Review, approval and issuance of certificates of analysis (COA) and text reports (MV/MT/MQ);  
• Review and approval of Empower audit trail, analytical test methods, and analytical protocols;
• Ability to train others on analytical QA techniques.;
• Participate in Rapid Response meetings for TrackWise record classifications;
• Review and approval of TrackWise Event, Deviations and Laboratory Investigations;
• Ability to make independent GMP decisions and provide QA consults to Lab partners;
• Participate in FDA inspections, mock PAI, customer and corporate internal audits when applicable;
• Periodic reviews and internal audit support when applicable;
• Follow GXP (e.g. GMP, GDP, etc.) as necessary to accomplish daily tasks;
• Participates in QA programs, procedures and controls to ensure that products conform to established standards and agency guidelines;
• Ensures that products are manufactured, packaged, tested and released according to applicable FDA guidelines, regulations GXPs and internal SOPs;
• Follows all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines;
•  All other duties as assigned

The Candidate:

• Master’s degree in a scientific discipline or equivalent with five(5) years of experience in an analytical laboratory or pharmaceutical manufacturing role; OR Bachelor’s degree in a scientific discipline or equivalent with seven (7) years of experience in an analytical laboratory or pharmaceutical manufacturing role: OR Associate degree in a scientific discipline or equivalent with ten (10) years of experience in an analytical laboratory or pharmaceutical manufacturing role
• At least one (1) year of experience in a Quality Assurance role in the pharmaceutical or medical device industry required
• Six Sigma or ASQ Certification preferred;
• Specialization in at least one of the following disciplines is preferred: Inhalation, Microbiology, Extractables and Leachables, Metals, Compendial Testing, Bio-Equivalence Studies, Analytical Stability, Method Validation, Transfers and Verifications;
• Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form;
• Ability to identify aberrant data and potential quality/compliance concerns escalating to management;
• 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 [email protected]. 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.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.