Quality Compliance Associate

Quality Compliance Associate Catalent is a global, high-growth, patient first 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.
Position Summary Quality Compliance Associate is responsible for the management of physical records and documents in support of Pre-Commercial and Commercial Operations and will assist in the document provision for Commercial Registration and On-Market Products.
The role assists with Client Audits and Regulatory Agency Inspections The Role Participate in and contribute as needed to support Client Audits and Regulatory Agency inspections.
Revise area related standard operating procedures (SOPs), as needed.
Obtaining and maintaining documents and other requested information to support Client and Site registration in appropriate files and locations.
Maintain hardcopy documentation and records, stored in Record Retention Rooms onsite with appropriate protection from fire, water and other damage.
Oversee Records Retention Room Control processes; ensure process is maintained for check in/out of critical records in inventory rooms; build process as needed to allow records to be removed from Record Retention Room, ensure return and filing/reconciliation by QA.
Ensure physical record safety and security throughout the retention period, through appropriate storage, filing, access and inventory control measures to assure compliance.
All other duties as assigned The Candidate Bachelor’s degree with at least 1 year of documentation management experience.
Associate degree with at least 2 years of documentation management experience.
Equivalent applicable years of experience in combination with education will be considered.
Average to proficient computer skills in word processing and internet-based applications Position requires the capacity to handle and manipulate objects using hands and arms.
Position requires the ability to safely lift and maneuver 30 pounds.
Sitting for long periods of time using a computer.
Why You Should Join Catalent Competitive medical benefits and 401K 19 days of PTO + 8 Paid Holidays Dynamic, fast-paced work environment Opportunity to work on Continuous Improvement Processes 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.