Senior QC Compliance Specialist

Senior QC Compliance Specialist About 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 QC Compliance Specialist to join our team supporting compliance in the Quality Control Analytical Laboratory. This role involves authoring, managing, and tracking investigations, events, deviations, and other quality records. The position also supports compiling, trending, and reporting key quality metrics for management accountability. The successful candidate will help ensure adherence to regulatory standards and continuous improvement of quality systems for GMP manufacturing of biological products.Shift: Monday - Friday, 8am-5pmLocation: Harmans, MD - BWI100% OnsiteThe RoleSupport and ensure timely initiation, documentation, and closure of QC CAPAs, investigations, deviations, and change controls.Track and trend aspects of Quality Control Systems and provide management reports identifying risks and trends.Collaborate with the Quality Systems group to perform QC CAPA effectiveness evaluations using quantitative and qualitative measures.Maintain tracking mechanisms to support QC analytical metrics.Monitor and review QC systems and procedures for compliance, quality improvements, and efficiency, providing compliance support to the QC department.Participate in QC compliance remediation plans and implementation.Assist with the generation and revision of GMP documentation such as standard operating procedures.Establish and execute a laboratory audit readiness program to ensure continuous compliance.Participate in QC internal audits as applicable.Contribute to site quality and process improvement initiatives and represent QC Analytical on project teams.Provide protocol generation and execution support for facility and utility qualifications and startups. Other duties, as assigned. The CandidateMinimum RequirementsBachelor's degree in biology or other life sciences discipline with 3–5 years of experience in a quality or compliance function.Experience with analytical and/or bioanalytical testing processes.Knowledge of scientific and regulatory principles with the ability to enhance quality systems; exposure to Lean Operational Excellence methodologies is highly desirable.Experience working in electronic systems such as Laboratory Information Management System (LIMS), Electronic Document Management System (EDMS), and Enterprise Resource Planning (ERP) systems is desirable.Experience with Good Manufacturing Practices (GMPs).Experience with the development, review, and approval of CAPAs, deviations, and investigations within the pharmaceutical or biologics industry, especially in analytical or bioanalytical laboratories.Experience with International Council for Harmonisation (ICH) Guidelines, United States Pharmacopeia (USP), and European Union (EU) GMPs.Quick to learn and navigate electronic systems, with the ability to work independently or collaboratively in fast-paced environments while applying strong troubleshooting and problem-solving skills.Preferred Skills & BackgroundExperience with ddPCR, qPCR, ELISA, pH, osmolality, appearance, CE-SDS, SDS-PAGE, and HPLC.PayThe anticipated salary range for this position in MD is $100,000 – $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 process.Diverse, inclusive culture.Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.Competitive paid time off plus 8 paid holidays.Community engagement and green initiatives.Medical, dental, and vision benefits effective day one of employment.Tuition reimbursement.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 View email address on click.appcast.io. 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 View email address on click.appcast.io for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice HERE.Volunteer Work Disclosure: Applicants for employment in Massachusetts may include in their employment history any verified work performed on a volunteer basis.Massachusetts Lie Detector Test Notice: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law may be subject to criminal penalties and civil liability. Consistent with Massachusetts law, Catalent does not require or administer lie detector tests as a condition of employment or continued employment.SummaryLocation: Harmans, MDType: Full time