Quality Assurance Specialist - Batch Disposition is responsible for providing Quality Assurance support for GMP documentation of master/working cell banks, bulk drug substance and finished drug product.
Responsibilities include but are not limited to GMP documentation review and supporting other QA functions as needed.
In this role, the individual is responsible for continuously monitoring systems and procedures to ensure compliance with applicable regulatory and industry standards, and to identify areas of opportunity and quality improvements.This position will be Mon - Thurs, 1st or 2nd shift (4 x 10 hr shifts ).
Occasional weekend/on-call work may be needed based on manufacturing needs.
**The Role:**- Review documentation for manufacturing activities associated with commercial, development, and engineering execution in accordance with good documentation practices (GDP), including but not limited to: executed batch records, master batch records, product labels, SMPs, and product specific documents- Independently executes batch record review for completeness, accuracy and cGMP compliance- Support the evaluation and lot disposition of intermediates, finish bulk drug substance and drug product.- Critically review various documentation types to ensure completeness, accuracy and compliance including but not limited to test methods, method validation protocols and reports and SOPs- Compile and report performance metrics for Batch Review and Release- Contributes to process improvement of batch records and associated processes (e.g.
turnaround times) to ensure all QA batch disposition deadlines are met- Ability to quickly process complex information and make critical decisions with limited information required- Oversee status of batches through disposition/release process and remove barriers, communicate escalations as appropriate- Communicate effectively with cross functional departments to ensure on time delivery of QA review and disposition responsibilities- Prepare reports and keep upper-level management informed of progressAct as QA reviewer for investigations, deviations and CAPAs appropriate and designated by QA Management.- Performs duties under limited supervision and according to standard operating and manufacturing procedures- Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory- Support on-the-floor quality issues in a timely manner, documentation of all events/investigations and required immediate corrective actions.- Perform tasks in a manner consistent with all Catalent policies including safety (EHS), quality systems and cGMP requirements- Understand risks and delays to batch release and communicate appropriately- Identify and participate in internal quality improvement initiatives: evaluate internal processes, suggest/design/ implement improvements, create/revise relevant SOPs- Participate in site and corporate quality and process improvement initiatives.
Represent QA on project teams and represent the Batch Disposition QA perspective as needed- Other duties, as necessary- Works in a collaborative team setting within the Batch Disposition team, within the quality department and with quality counterparts including Manufacturing Operations, Technical Support, Supply Chain and Planning.- Interacts with the quality team and internal stakeholders to support the development, manufacturing, testing, packaging, and release of cell and gene therapy products**The Candidate:**- Minimum of a B.S., Life Sciences discipline preferred- +4 years experience within the biologic, biopharmaceutical, pharmaceutical or regulated industry - +2 years experience in a Quality Assurance/Quality Control or Manufacturing function - Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks- Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish preferred - Strong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.- Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish.
- Ability to quickly learn new and novel manufacturing processes supporting new clients- Able to work in a team setting and independently under minimum supervision- Familiarity with electronic systems, including developing and producing reports using Microsoft Office (Excel)- Requires the ability to produce results in a fast-paced environment to meet client deadlines**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 firstname.lastname@example.org for us to investigate with local authorities.
Location/Region: Harmans, MD (21077)