Senior Specialist QA OTFAbout SiteOur FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our Baltimore location. The campus is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies.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.Position SummaryWe have an opportunity for a Senior Specialist QA OTF Support to join our team. This role provides Quality Assurance support for GMP manufacturing of master and working cell banks, biological bulk drug substance, and finished drug product for human use. You will ensure compliance by observing manufacturing operations and reviewing documentation on the floor. The position focuses on maintaining quality standards, supporting continuous improvement, and ensuring adherence to regulatory requirements for biological products.Shift: Monday – Friday, 8am-5pmLocation: Harmans, MD - BWI100% OnsiteThe RoleProvide dedicated QA quality floor oversight of GMP operations for manufacturing of cell banks, bulk drug substance, and final drug product, spending 75% of the day on the floorPerform QA on-the-floor activities including room release, observing critical processes, reviewing batch documentation in real time, and resolving issues during manufacturingPartner with Manufacturing and other support teamsPerform Acceptable Quality Limit (AQL) visual inspection of drug productReview and approve batch documents for media and buffer preparation solutionsGenerate or revise GMP documentation such as Standard Operating Procedures, Master Batch Record review, and SMPsCompile deviations observed on the floor and ensure timely completionPerform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation PracticesMake quality decisions with limited oversightIdentify and implement continuous improvement initiativesParticipate in site and corporate quality and process improvement initiativesGuide personnel involved in GMP operations on compliance, internal procedures, regulatory requirements, and industry best practicesActively participate in training activities and manage individual training planOther duties as assignedThe CandidateMinimum RequirementsMaster’s degree in a Scientific, Engineering, or Biotech field with 2–4 years of experience in Quality Assurance, Quality Control, or Manufacturing within biologics, biopharmaceuticals, or a regulated industry, ORBachelor’s degree in a Scientific, Engineering, or Biotech field with 4–6 years of experience in Quality Assurance, Quality Control, or Manufacturing within biologics, biopharmaceuticals, or a regulated industryFamiliarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210 and 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines, and EU GMPsKnowledge and/or exposure to biological manufacturing processes including microbial and cell culture cell banking, fermentation/cell culture, purification, and fill/finishAbility to apply basic scientific and regulatory principles to solve operational and routine quality tasksFamiliarity with electronic systems and ability to develop and produce reports using Microsoft productsCreative individual with strong analytical, troubleshooting, and decision-making skillsAbility to quickly learn new manufacturing processes supporting new clientsAble to work in a team setting and independently under supervisionAbility to deliver results in a fast-paced environment to meet client deadlinesPreferred Skills & BackgroundKnowledge of LIMS, Master Control, and Trackwise systems preferredPayThe anticipated salary range for this position in MD is $105,000 – $120,000 Plus Bonus. 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 CatalentDefined career path and annual performance review and feedback processDiverse, inclusive culturePotential for career growth on an expanding team within an organization dedicated to preserving and bettering livesCompetitive paid time off plus 8 paid holidaysCommunity engagement and green initiativesMedical, dental, and vision benefits effective day one of employmentTuition reimbursementCatalent 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.