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QA Specialist

Company: Catalent
Location: Baltimore
Posted on: January 16, 2022

Job Description:

QA SpecialistPosition Summary Catalent Gene Therapy is looking to recruit a QA Specialist to join our growing team in Baltimore, MD.QA Specialist is responsible for providing QA support for Client Projects and GMP Operations from start to finish 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 critical processes and performing AQL visual inspection, executed GMP documentation review and supporting other QA functions as needed.Catalent Gene Therapy 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. The Role Perform audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and industry best practicesReview and dispositions executed batch records and supporting documentation for completeness, accuracy and complianceAct as first responder for quality issues and actively pursue timely, compliant closure and documentation of all events and investigations and required immediate corrective actions. Participates in root cause analysis using methodologies, such as: fishbone, 5 whys, comparative analysis, etc.Act as QA reviewer for investigations, deviations and CAPA; with limited approval authority as designated by QA Management.Performs QA on the Floor activities supporting client projects, including room release, observing critical processes, reviewing documentation in real time, and resolving issues that occur during manufacturing. Also perform Acceptable Quality Limit (AQL) visual inspection of drug productWrite, revise and approve GMP documentation as necessaryWorks cross-functionally with Project Management, Manufacturing, Facilities, and Quality Control in meeting project deliverables in a compliant and efficient mannerParticipate in site and corporate quality and process improvement initiatives. Represent QA on project teams and represent QA perspective as necessary.The Candidate B.S. in a Life Sciences discipline and 2+ years of relevant experience - OR - M.S. in a Life Sciences discipline - OR - 5 years of relevant experience without a degreeFamiliarity with Good Manufacturing Practices (GMPs), 21 CFR 210/211/600s, USP and ICH GuidelinesHave the knowledge, and ability to apply basic scientific and regulatory principles utilized to solve operational, as well as routine quality tasksExposure to Lean Operational Excellence highly desirableStrong knowledge base with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.Catalent's standard leadership competencies that are used to interview and for Performance & DevelopmentLeads with Integrity and RespectDelivers ResultsDemonstrates Business AcumenFosters Collaboration and TeamworkChampions ChangeEngages and InspiresCoaches and DevelopsPosition BenefitsPotential for career growth within an expanding teamDefined career path and annual performance review & feedback processCross functional exposure to other areas of within the organizationMedical, Dental, Vision, and 401K are all offered from day one of employment19 days of paid time off annually + 8 paid holidaysCatalent 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. Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.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 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 for us to investigate with local authorities.

Keywords: Catalent, Baltimore , QA Specialist, Other , Baltimore, Maryland

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