Analytical Quality Associate I

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 I. Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. Comply with divisional and site Environmental Health and Safety requirements.

This is a full-time on-site role. The core hours are Monday – Friday 9:00AM – 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:

Review, approval, and issuance of the following project types ensure that products conform to established standards and agency guidelines. Certificate of Analysis (CoAs), Text Reports (i.e. Method Validation, Method Transfer, etc.), New methods, protocols, and revisionsReview and approval of Empower audit trails.Performs project archival and pack-outs.Ensures Good Documentation Practices and cGMPs are followed to ensure inspection readiness and regulatory compliance to applicable FDA guidelines and regulatory agency guidelines.Meets deadlines according to agreed timeframes and “standard work” as defined by the Manager; communicates adjustments as needed.Participates in/Provides support to QA programs (i.e., internal audits, laboratory walkthroughs, regulatory inspection readiness activities),All other duties as assigned

The Candidate:

Master’s degree in a scientific discipline or equivalent with two (2) years of experience in an analytical laboratory or pharmaceutical manufacturing role; OR Bachelor’s degree in a scientific discipline or equivalent with four (4) years of experience in an analytical laboratory or pharmaceutical manufacturing role; OR Associate degree in a scientific discipline or equivalent with seven (7) years of experience in an analytical laboratory or pharmaceutical manufacturing role;Minimum of 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, Compendial Testing, Analytical Stability, Method Validation, Transfers and Verifications;Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form;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 innovativePotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 152 Hours + 8 paid holidaysSeveral Employee Resource Groups focusing on D&IDynamic, fast-paced work environmentCommunity engagement and green initiatives Generous 401K match Company match on donations to organizationsMedical, 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 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.

    

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 spam@catalent.com for us to investigate with local authorities.

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