We are searching for an experienced Manufacturing Quality Associate II to join our high calibre team at Catalent in Morrisville, NC.
Growing your career as a Full Time Manufacturing Quality Associate II is an amazing opportunity to develop productive skills.
If you are strong in adaptability, critical thinking and have the right mindset for the job, then apply for the position of Manufacturing Quality Associate II at Catalent today!
Catalent Pharma Solutions is Morrisville, NC is hiring a Manufacturing Quality Associate II team member who supports manufacturing facility inspection operations. Candidate should have prior GMP inspection experience within a pharmaceutical manufacturing facility or equivalent. Candidate must be detail oriented in a fast-paced multi-task environment with good oral and written communication skills and have the ability to interact with all levels of management and all departments. Facility operates 24/5 with scheduled weekend work anticipated. The Quality Associate II position requires moderate independent judgment with some direct supervision under non-routine circumstances. Position requires some degree of initiative to resolve problems. This is a full-time role position: Monday - Thursdays, 2pm - 1230am . This position is onsite.
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 andcompliance, and to the safety of every patient, consumer, and Catalent employee. The Role Provide QA support to manufacturing for clinical and commercial batches in compounding, filling and packaging operations Performs Line Clearances, equipment releases, AQL inspections and real-time batch record review on the shop floor Liaise with manufacturing and peers Perform material releases Place non-conforming material and product On Hold Assist with batch investigations and final review and approval of executed batch records and resolve identified discrepancies and reported nonconformances Perform classification of non-conforming investigations and closure of events Provide QA support for non-conforming investigations Support release of finished product Rotational weekend work to support manufacturing All other duties as assigned The Candidate Requires BA or BS in Life Sciences or combination of education and equivalent work experience with at least two years of experience in manufacturing and/or quality Good understanding of compliance, regulations, and inspection techniques Thorough knowledge of cGMPs, ability to evaluate facilities records, processes, procedures, and practices for conformance to these requirements Should have knowledge of current industry expectations of analytical testing requirements for primary and secondary packaging components Understanding of statistical sampling methodologies Ability to organize time for multiple tasks (major projects and daily functions) handle multiple projects and deliver on project timelines with little supervision Knowledge of cGMP, GLP, ICH, and USP regulations or guidelines for US (FDA) and other regulatory bodies (EU, Health Canada, etc.) 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 19 days of PTO + 8 paid holidays Several Employee Resource Groups focusing on D&I Dynamic, fast-paced work environment Employee Stock Purchase Program 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 matchand 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 View email address on hirelifescience.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 View email address on hirelifescience.com for us to investigate with local authorities.
California Job Seekers can find our California Job Applicant Notice HERE .
Benefits of working as a Manufacturing Quality Associate II in Morrisville, NC:
? Company offers great benefits
? Advancement opportunities
? Competitive salary
