Senior QA Technical Reviewer

Senior QA Technical Reviewer

Position Summary

This position is responsible for the overall Quality Assurance review of all technical documents, as they relate to a) process improvement projects; b) all equipment IQ/OQ/PQ documents regarding equipment, utilities, and computer systems; c) all product process validation and cleaning validation documents; d) all Preventive Maintenance and Calibration work order requirements for critical systems e) Deviation and complaint investigation reports. Furthermore, this position will participate in the internal audit program as well as customer audits.

St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year.  Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.

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, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.

This position is 100% on-site at the St. Petersburg site.

The Role

• Provide QA Technical support during the development and manufacturing improvements throughout the design phase, technical transfers and routine production.

• Ability to investigate and analyze technical reports and technical concerns to determine trends affecting future designs, production activities.

• Provide QA Technical recommendations based on trend analysis to eliminate future problems.

• Participates in various project meetings to provide Quality Assurance input with respect to compliance to cGMP requirements.

• Reviews and approves technical documents, such as: Technical Protocols and Reports, Process

• Validation Protocols and Reports, Cleaning Validation Protocols and Reports, IQ/OQ/PQ Protocols and Reports and, Change Control, as it pertains to the above validated/qualified systems.

• Reviews and approves deviation investigations with particular attention to suggested root cause and CAPA to ensure appropriate actions are identified to prevent occurrence/reoccurrence

• Provides feedback to the appropriate department (i.e. regarding the compliance and adequacy of the documents reviewed as it pertains to cGMPs, site SOPs and regulatory guidelines).

• Approve documents as designated by QA management.

• Other duties as assigned.

The Candidate

• Bachelor’s degree in Science or Engineering with minimum of 3 years of related experience in QA pharmaceutical manufacturing and/or Manufacturing pharmaceutical operation.

• Prior experience working with technical review, investigation writing, including root cause analysis and report writing is a must. 

• Proficient to Advance knowledge of Microsoft programs required (Excel, Word, Access and PowerPoint). Experience with Documentum, TrackWise, and JD Edwards is preferred.

• Proficient (excellent) English verbal and written communication skills to communicate with all levels of the organization in various functional areas and receive ideas and instructions to/from others within and outside the organization and effectively present information and respond to questions from site management.

• Ability to work in a cross-functional team environment.

• Proven ability to multi-task and demonstrate diplomatic skills.

• Must possess solid technical expertise as it relates to manufacturing processes, decision-making skills, and the ability to solve problems with minimal guidance. 

• Ability to identify root cause of problems and offer solutions, which address causes, rather than

• symptoms. 

• Working knowledge of cGMPs and/or OSHA regulations required.

• Ability to work effectively under pressure to meet deadlines. Individual required to sit, stand, walk and lift 0-15 pounds; no lifting greater than 44.09 pounds without assistance. Be accessible to manufacturing floor and office staff and to use required office equipment. Specific vision requirements include reading of written documents and use of computer monitor screen frequently.

Why You Should Join Catalent 

• Competitive medical benefits and 401K 

• 152 hours 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. 

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.