Senior Specialist, Client QA - Severn Maryland

Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/07/2025

Sr Specialist, Client QAPosition SummaryCatalent, 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.Catalent's Harmans/BWI, MD facility is a FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies. The campus features two manufacturing facilities: The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing. Both facilities support Phase 3 through commercial manufacturing of advanced therapeutic products including AAV and other viral vector-based therapies and vaccines.The Sr. Specialist, QA is responsible for providing QA support and oversight of Client Projects from start to finish for GMP Manufacturing of master/working cell banks, biological bulk drug substance and finished drug product. --Client QA serves as the dedicated Client QA Representative and liaisons with the Client and other functions including Project Management, ProcessDevelopment, Technology Transfer, Manufacturing, Quality Control and other functions within the Quality Assurance unit. Responsibilities include tracking and reviewing technology transfer documents, specifications, master batch records, change requests, deviations and failure investigations supporting the release of manufactured material.--This position is 100% on site on 1st shift Monday-Friday 8AM-5PM at our Harmans, MD facility.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:

• Provides dedicated QA support to client projects and client interactions & meetings; involved from inception of a client's project until project closure. Supports Clinical and Commercial QA activities, including initial process development and non-clinical batch production.
• Tracks, documents and presents Quality Metrics presentations for Client Projects (on time batch release, right first time, deviations per batch); works with clients during initial and subsequent manufacturing campaigns--
• Provides quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance and/or final drug product; conducts review of master batch records during Technical Transfer for client processes--
• Supports GMP departments in reviewing and approving deviations and failure investigations, including root cause analysis, evaluating product/facility impacts, and evaluating effective corrective and preventive actions (CAPAs) ; performs risk analysis and mitigation, using available tools such as FMEA, when needed.--
• Maintains databases and systems used for tracking various GMP manufacturing associated support activities; assists with the review and approval of GMP documentation such as Standard Operating Procedures--
• Support regulatory (i.e. FDA, EMA) and client audits/inspections; assists with internal audits of GMP systems and facilities--
• Works cross-functionally with Project Management, Pre-Clinical Services, Manufacturing, Facilities, Quality Control and other departments to resolve quality issues and provide assistance when needed; actively participates in training activities, managing their individual training plan.
• Other duties as assigned.The Candidate:
  • Masters' degree in a Scientific, Engineering or Biotech field with 2 - 4 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry OR Bachelor's degree in a Scientific, Engineering or Biotech field with 4 - 6 years' experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.--
  • Knowledge within 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.
  • Familiarity with electronic systems, including developing and producing reports using Microsoft products. LIMS, Master Control and Trackwise knowledge preferred. --
  • Ability to quickly learn new and novel manufacturing processes supporting new clients; 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--The anticipated salary range for this position in Maryland is $93,280-128,260 plus annual bonus, when eligible. --The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.Why you should join Catalent:--- -- --Defined career path and annual performance review and feedback process----- -- --Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives----- -- --Dynamic, fast-paced work environment--- -- --Generous 401K match and Paid Time Off accrual----- -- --Medical, dental and vision benefits effective day one of employment----- -- --Tuition Reimbursement----- -- --Wellhub program to promote overall physical wellness----- -- --Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories--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 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 . 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 . More...

        

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