The Principal Technician, QA – Document Control is responsible for the issuance, revision and tracking of controlled documents used to support the Phase I/II/III and commercial GMP manufacture of bulk and sterile fill biologics. Duties include but not limited to change control, revising existing documents, obsolete outdated documents, and ensure that all documents are handled in a controlled manner consistent with documentation policies and departmental SOPs.

Catalent, 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.

The role:

Will work directly with Clients, the QA department and other Catalent departments to revise, issue and track controlled documents to meet timelines. Provide status updates and reminders when necessary.Issuing, tracking and control (both electronic and hardcopy) of all documentation to include but not limited to: Quality Manual, Company Policies, SOP’s, forms, Validation Protocols and Reports, Material Specifications, and Master Batch Records.  This includes formatting, editing, and revision of documents and tracking document change request forms through the document review and approval process.Revising and updating departmental SOP’s as necessary.Insures revision control for all documents and forms.  Send company notification of new approved documents and revisions.Formats, edits and controls electronic templates for batch records, SOP’s, Company Policies, Validation Protocols, etc.Issuance and control of lab notebooks and logbooks.  Creates and binds in-house logbooks per specified forms.  Responsible for archiving and tracking of used lab notebooks and logbooks.Responsible for systematically maintaining manual file storage for large volumes of documents.  File master documents and executed documents as necessary.Accountable for entry of document related information into applicable logs, both manual and electronic, for tracking and accountability purposes.Assists with company audits by regulatory agencies and external clients.  Retrieve and photocopy any requested documents and track the documents requested.

The candidate:

High school diploma and 5 - 7 years’ experience within biologics, biopharmaceuticals, or medical device industries in a Document Control position, including the revision, issuance and tracking of batch records, Standard Operating Procedures (SOP), Specifications, etc.Ability to write correspondence for internal and external client communications.Comply with FDA and EU cGMPs and Regulations.Strong knowledge with 21 CFR Parts 210 & 211, biotechnology and electronic validated computer systems a plus.Ability to speak effectively and communicate directly with all levels of personnel in the company.Excellent attention to detail, word processing accuracy, organizational and prioritization skills.Strong knowledge with electronic systems, including developing and producing reports using Microsoft Access and Excel knowledge preferred.

The anticipated salary range for this position in Maryland is $74,080 to $101,860 plus an annual bonus target. 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:

Competitive medical benefits and 401K152 hours PTO + 8 Paid HolidaysDynamic, fast-paced work environmentOpportunity to work on Continuous Improvement Processes

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 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:

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