Catalent Pharma Solutions QA Product Manager in St. Petersburg, Florida
QA Product Manager
Is making an impact important to you? The QA Product Manager will support the local site by being responsible for the overall Quality Assurance review and approval of all technical documents including but not limited to: a) change controls and associated Master documents, including but not limited to MERs and material Specifications; Product specifications; Test methods; Master Batch Records; Master Shipper Labels; all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; b) process improvement projects and Product Development Projects; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance and Calibration work order requirements for critical systems.
Are you ready to improve people’s lives every day?
JOB TITLE REPORTS: Quality Assurance Manager
The Quality Assurance Department is responsible for providing Leadership and Quality Assurance Management support within at Catalent’s St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.
The Role (daily responsibilities)
Primary quality liaison for clients and internal customers. Is expected to become the Subject Matter Expert for the client products, processes and requirements.
Responsible for maintaining, developing, and nurturing the client partnership to ensure alignment and consensus.
Effective coordination of functions across the site and with clients to drive timely review, approval, and closure of investigations, change controls, audit tasks, corrections, and effectiveness checks.
Participates in Product Development/Validation/Engineering project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements.
Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities.
The Candidate (requirements)
Bachelors Degree in Science (Chemistry, Microbiology or Biology preferred) required or equivalent;
A minimum of five to ten years related experience and/or training and/or equivalent combination of education and experience in the QA pharmaceutical industries.
Prior experience working with validation, manufacturing or product development preferred.
Proven ability to multi-task and demonstrate diplomatic skills.
Must possess excellent English verbal and written communication skills.
Intermediate to proficient skills in Microsoft Office applications.
Cross functional exposure to other areas of Operations
Medical, Dental, Vision and 401K are all offered from day one of employment
19 days of paid time off annually + 7 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. More products. Better treatments. Reliably supplied. ™Visit www.catalent.com/careers to explore career opportunities.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a 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.
Catalent offers rewarding opportunities to further your career – join the global drug development and delivery leader! You will help develop some of the nearly 200 products we launch each year or help supply some of the over 7,000 products for patients around the world. Our highly skilled, dedicated global team of over 9,500 is passionate about improving the health of patients by combining their personal expertise with advanced technologies to advance science and supply innovative new products of the highest quality to patients globally.
Gain unparalleled experience by working on multiple products and technologies – we launch nearly 200 new products for our customers each year.
We have 20 global pharmaceutical Product Development teams on five continents, who are, at any given time, working on over 700 new products and hundreds of ongoing clinical trials.
Our products include some of the latest life-saving medicines as well as some of the most well-known consumer health brands used by families every day.
Catalent’s more than 30 global facilities on 5 continents manufacture over 70 billion doses of over 7,000 important medicines and consumer health products.
Nearly 1 in 20 doses of medicines taken around the world has been touched by the Catalent team.
We have +1,100 patents on many superior patient-preferred technologies used by all the top pharmaceutical, biologic and consumer health companies.
We established the Catalent Applied Drug Delivery Institute to drive collaboration and scientific exchange among industry professionals, academics and partners.
Many of our 1,400+ scientists are regularly published in top industry journals and present at top industry conferences to advance knowledge sharing and the development of better life-saving medicines.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.