Manufacturing Document Control Specialist

Nature and Scope

The Manufacturing Documentation Control Specialist will author, edit, review, evaluate, and maintain GMP documentation (Manufacturing SOPs, Manufacturing Batch records, etc). The individual will co-ordinate with Document Control and Change Request reviewers from the documents initiation to the approval stage.

The Documentation Control Specialist will be responsible for authoring/revising documents in a pharmaceutical environment, requiring the ability to digest complicated technical subject matter and work with incomplete information in a fast-paced, continually changing environment and ability to effectively communicate between various departments (QA, QC, DC, etc.)

Essential Duties and Responsibilities

• Draft and revise SOP's and manufacturing batch records.

• Provide editorial support and ensure quality of all document content; focus on clarity, accuracy and consistency, while maintaining adherence to proper formats, regulatory requirement and company procedures and guidelines.

• Manage the Change Control process for documents generated or revised within Manufacturing.

• Initiate and manage document reviews and revision to achieve clear, concise and accurate instructional documents.

• Manage and track the status of documents being drafted or undergoing revision within Manufacturing.

• Procure and distribute templates from Document Control for the generation of new documents.

• Ensure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP requirements.

• Develop and maintain expertise through interaction with subject matter experts.

• Perform any other tasks/duties as assigned by management.

Education Requirements and Qualifications

• High School Diploma or GED equivalent required. Associates or Bachelor's Degree preferred.

• Experience with the fundamentals of document management and the management of the document life cycle, preferred.

• Ability to perform multiple activities at the same time and produce outstanding results to meet required deadlines.

• Excellent writing and editing skills, with a keen attention to detail.

• Excellent organizational, interpersonal, and communication skills (oral and written).

• Proficient in Microsoft Office applications.

• Ability to work overtime as needed

Physical Environment and Requirements

• Physically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves. PPE is essential for the health and safety of employees.

American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.

Applicants have rights under Federal Employment Laws.

• FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdf
• Know Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)
• Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdf

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