Analytical Quality Assurance Associate

Position Summary: Catalent Pharma Solutions is Morrisville, NC is hiring a Analytical Quality Assurance Associate for the Analytical group.
The Analytical Quality Associate will perform routine auditing of pharmaceutical projects, using established procedures, and independently perform routine work with progressively more involvement in recommendations for the improvement of the department This is a full-time position: Monday – Friday, 8:00AM-5:00PM.
Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide.
Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.
The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.
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, approve, and issue certificates of analysis Review and approve Empower audit trail Perform project archival and pack-outs Follow GXP (e.
g.
GMP, GDP, etc.
) as necessary to accomplish daily tasks Participate in QA programs, procedures, and controls to ensure that products conform to established standards and agency guidelines Meet deadlines according to agreed timeframes and communicate adjustments as needed Follow all Good Documentation Practices and cGMPs to ensure compliance to applicable FDA guidelines and MHRA guidelines All other duties as assigned; The Candidate This position is entry level with a Bachelors in a related field In lieu of a Bachelors degree we can accept relevant experience Must be able to follow a variety of instructions furnished in written, oral, diagram, or schedule form Microbiology experience is strongly preferred Strong written and verbal communication skills High level of organizational skills are required Working knowledge of cGMP, GLP, ICH, and USP regulations or guidelines is strongly preferred Requires contact with multiple departments and on occasion with customers 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 152 hours of PTO + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment 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 Competitive salary with bonus potential Community engagement and green initiatives Generous 401K match and Paid Time Off accrual Medical, dental and vision benefits effective day one of employment Tuition Reimbursement – Let us help you finish your degree or earn a new one! GymPass 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.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve.
As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety.
The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
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.