Manufacturing Document Control Specialist

Nature and Scope

The Manufacturing Document Control Specialist will author, edit, review, evaluate, and maintain GMP documentation (Manufacturing SOPs, Manufacturing Batch records, Protocols, Reports, Specifications, etc.). The individual will co-ordinate with Document Control and Change Request reviewers from the document's initiation to the approval stage. The Manufacturing Document Control Specialist will also work on and maintain compliance expectations for Corrective and Preventative Actions (CAPAs), Change Controls, Annual Product Reviews (APRs), and Media Fill documents.

The Manufacturing Documentation Control Specialist must have: Experience in authoring/revising documents in a pharmaceutical environment, 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

Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time.

• Draft, revise, and maintain controlled documents including Standard Operating Procedures and product masters/modules (OH/NY), as well as specifications, protocols, reports, and other miscellaneous documents, (NY). Collaborate with department SMEs and incorporate applicable feedback into process and document changes. (OH/NY)

• 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. (OH/NY)

• Manage the Change Control process for documents generated or revised within Manufacturing. Ensure Change Controls for the process and document related changes are completed or extended before the due date while working with the QA Change Control team. (OH/NY)

• 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. (OH/NY)

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

• Ensure CAPAs for SOP revisions, report generation, and general process changes are completed or extended before the due date while working with the QA CAPA team. (NY)

• Perform training impact assessments for document change controls by reviewing module assignments and revising applicable document assessments. (NY)

• Assist in the Media Fill execution by revising media fill documents, reviewing and compiling batch record data, etc.). (NY)

• Provide support for manufacturing projects (i.e., data mining, protocol/report authoring, manufacturing line efficiency). (NY)

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

• Perform data entry to support Annual Product Reviews, where applicable. (NY)

• Perform tasks with a minimal error rate. Perform any other tasks/duties as assigned by management. (OH/NY)

Education Requirements and Qualifications

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.

• High School Diploma or GED equivalent required. Associate or bachelor's degree with technical writing preferred.

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

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

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

• Develops and maintains expertise through interaction with subject matter experts.

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

• Proficient in Microsoft Office applications including Word and Excel, required.

• Takes initiative with minimal supervision.

• Ability to identify, manage, negotiate, and resolve issues independently.

• Must be able to read documents in Standard English such as Standard Operating Procedures, maintenance schedules and operating manuals.

• Ability to take feedback constructively and function in a team-oriented work environment.

• Must be able to work independently, recognizing what needs to be done and accomplishing it with minimal supervision.

• 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.

• Employee must be able to occasionally lift and/or move up to 25 pounds.

Expected hourly range:

$26.11 - $29.50

The hourly range displayed is the minimum and maximum hourly rate for the role that the employer in good faith believes to be accurate at the time of the posting of an advertisement for the role. Actual compensation for the role will be based on a number of different factors including but not limited to the candidate's qualifications, education, knowledge, skills and experience.

American Regent also offers a competitive total rewards package which includes healthcare, life insurance, profit sharing, paid time off, matching 401k as well as a wide range of other benefits.

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

American Regent Inc. endeavors to make https://americanregent.com/Careers accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email hrtalentacquisition@americanregent.com.