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Lead QA Specialist - Client QASONARA • Annapolis, Maryland, United States
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Lead QA Specialist - Client QA

SONARA
  • US
    Annapolis, Maryland, United States
  • US
    Annapolis, Maryland, United States
Postuler Maintenant

À propos

Lead Specialist, Client QA Position Summary: Work Schedule: Monday‑Friday, 8am‑5pm. 100% on‑site.
Catalent is a leading global CDMO partnering with pharma and biotech innovators to accelerate development and delivery of life‑changing therapies. Our FDA‑licensed, state‑of‑the‑art CGMP gene therapy campus in Harmans, MD—just minutes from BWI Airport—features EMA and FDA‑approved manufacturing suites, fill/finish capabilities, labs, and warehousing to support Phase 3 through commercial production of advanced therapies, including AAV and other viral vector‑based products.
The Lead Specialist, QA is responsible for providing QA lead 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. Acting as the dedicated Client QA Representative, you will oversee projects from start to finish—partnering with cross‑functional teams in Manufacturing, Process Development, Technology Transfer, and Quality Control. Your work includes reviewing and tracking critical GMP documentation such as technology transfer records, specifications, master batch records, and investigations, all supporting the release of life‑changing therapies.
The Role
Provide dedicated QA support for client projects and client interactions, serving as the primary QA contact throughout the project lifecycle.
Provide quality oversight of GMP operations for the manufacture of master/working cell banks, bulk drug substance, and/or final drug product.
Support clinical and commercial QA activities from process development through non‑clinical and commercial production.
Track and present key quality metrics for client projects, including batch release timelines and deviation trends.
Collaborate with clients during initial and subsequent manufacturing campaigns to ensure compliance and quality standards.
Review and approve master batch records during technology transfer for client processes.
Support 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).
Perform risk assessments and mitigation strategies using tools such as FMEA.
Maintain and update systems and databases for tracking manufacturing and quality activities.
Support audits and inspections by regulatory agencies and clients and assist with internal GMP audits.
Other duties as assigned.
The Candidate
Master’s degree in a Scientific, Engineering, or Biotech field with a minimum of 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 a minimum of 6 years’ experience in Quality Assurance/Quality Control within biologics, biopharmaceuticals, or a regulated industry.
Strong knowledge base with Good Manufacturing Practices (GMPs), 21CFR Parts210,211, biological regulations per 21CFR Parts600s, ICH Guidelines and EU GMPs.
Knowledgeable and/or exposure to biological manufacturing processes including microbial and cell culture 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.
Creative individual with strong analytical, troubleshooting, and decision‑making skills to resolve complex issues effectively.
Ability to quickly learn new and novel manufacturing processes supporting new clients.
Proven ability to work independently and in cross‑functional teams, delivering high‑quality results in a fast‑paced, deadline‑driven environment while meeting client and regulatory requirements.
Salary The anticipated salary range for this position in Maryland is $118,000 to $145,000 plus an 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.
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, confirming your request for an accommodation and including 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.
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.
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  • Annapolis, Maryland, United States

Compétences linguistiques

  • English
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