Quality Assurance Associate

1 week ago

Winchester, United States Catalent Inc Full time
Quality Assurance Associate

Position Summary

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. 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.

Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology.

The QA Associate is responsible for the Quality support functions associated with the manufacturing of solid oral dosage products for a given business unit. The essential responsibilities associated with this position are oversight of the manufacturing operations (as dictated by cGMP, CFR, and Catalent SOP) through document review/approval, real time monitoring/approval of manufacturing activities and testing/approval of in-process and finished product samples.

The Role
  • Recommend SOP and batch record changes as needed
  • Review proposed SOP revisions and provide feedback to management
  • Real-time audit of batch records in the production suites for completeness, documentation, calculation errors and conformance to critical process parameters
  • Perform room and equipment clearances per procedure following cleaning conducted by production.
  • Perform microbial swabbing of equipment and room surfaces for environmental monitoring.
  • Maintain a full understanding of all Catalent SOPs and policies along with all cGMP and CFR guidance that are applicable to the manufacturing of solid oral dosage pharmaceutical products.
  • Perform routine testing of in-process and finished product samples including particle size, bulk density, moisture analysis, appearance, and AQL testing real-time.
  • Other duties as assigned.
The Candidate
  • Bachelor's Degree in related science or technical field preferred with 2 years prior work experience
  • Minimum of High School Diploma with 4+ years of relevant experience in a regulated GMP manufacturing environment.
  • Additional qualifications desired are Lean Six Sigma, ASQ certification or other professional certification
  • Safe work habits
  • Basic math and computer skills
  • Good communication skills
  • Ability to follow written and verbal instructions
  • Able to work with limited supervision for routine tasks
  • Excellent documentation and handwriting skills
  • Proficient reading and comprehension skills
  • Sound decision-making, technical and problem-solving skills
  • Good time management skills
  • Expert technical writing and problem-solving skills
  • Good Laboratory Practices
  • Experienced with continuous improvement techniques
  • Demonstrates initiative
  • This employee will assist other personnel with lifting of liquid containers and all objects of greater than 50 lbs
Why You Should Join Catalent
  • Several Employee Resource Groups focusing on D&I
  • Employee Stock Purchase Program
  • Tuition Reimbursement - Let us help you finish your degree or earn a new one
  • Generous 401K match
  • 152 hours accrued PTO + 8 paid holidays

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.

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