APPLY: Sr. Specialist, QA OTF Support Job in Harmans, Maryland, United States of America, 21077 | Catalent Careers

The Senior Quality Assurance Specialist, OTF provides Quality Assurance support for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product to be used for human consumption. Responsibilities include providing QA on the Floor oversight of manufacturing including observing manufacturing operations and reviewing documentation for compliance. Executing assigned quality tasks (including pre-approving instructions, reviewing documentation of executed instructions, reporting metrics, document drafting, report writing), providing review and approval of change requests (e.g., Trackwise change controls and EDMS document change requests), approving item masters, product specifications and materials for usage in manufacturing, providing direction for and reviewing and approving deviations, corrective and preventive actions, risk assessments, and reviewing resolution and effectiveness of corrective actions and audit responses.

This position is 2nd Shift Tues-Fri 3PM-1:30AM.

Catalent hires people with a passion to make a difference. Your expertise, coupled with our advanced technologies and collaboration with innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that 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.

The Role:

• Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing batch documentation in real time, cleaning documentation, logbooks and resolving issues that occur during manufacturing.
• Perform Acceptable Quality Limit (AQL) visual inspection of drug product
• Review and approve batch documents for media and buffer prep solutions; Generate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review and SMP’s; Compile deviations as required when observed on the floor, and move to completion within the required time frame; Provides dedicated QA quality floor oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product – 70% of day is spent on the floor.
• Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices.
• Provides QA support and escorting of Client Person in Plant (PIPs), if required; Act as QA reviewer for events/deviations and CAPA issuance; Make solid quality decisions with limited oversight.
• Identify and implement and continuous improvement initiatives and participate in site and corporate quality and process improvement initiatives.
• Represent QA on project teams and represent QA perspective as necessary and guides personnel indirectly and directly involved in GMP operations pertaining to cGMP compliance, internal procedures, regulatory requirements and industry best practices. Partner with Manufacturing and other support teams.
• Other duties as assigned.

The Candidate

• Bachelor’s degree required; STEM preferred.
• Master’s degree preferred.
• 5+ years’ experience within the biologic, biopharmaceutical, or regulated industry; 3+ years’ experience in Manufacturing/Quality Assurance/Quality Control function 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; Experience or knowledge in Trackwise preferred.
• Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification and fill/finish; Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasks.
• Creative individual with excellent trouble shooting and decision-making skills; Ability to quickly learn new and novel manufacturing processes supporting new clients who is able to work in a team setting and independently under minimum supervision; Requires the ability to produce results in a fast-paced environment to meet client deadlines with strong technical and quality background.
• Able to effectively interpret new and existing global regulations and to communicate effectively with all levels of personnel and regulatory inspectors; Clear problem-solving and decision-making skills with the ability to function well in a changing environment.

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement
• 19 days of PTO + 8 paid holidays
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• Generous 401K match and Paid Time Off accrual
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• GymPass program to promote overall physical wellness

Preferred dress code

Business (business suit, tie)

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