Inspection and Packaging Document Control Coordinator I

Nature and Scope

 The Inspection and Packaging Document Control Coordinator I works with the Inspection and Packaging department in the activities associated with the Inspection and Packaging GMP documentation (Manufacturing SOPs, Manufacturing Batch records, protocols, reports, specifications, etc.) in accordance with company procedures and cGMPs. The Inspection and Packaging Document Control Coordinator I ensures work is completed in a timely manner and in accordance with company standards. The role plays a critical role in assuring safe, effective and compliant activities are performed in the Inspection and Packaging department and plays a critical role in maintaining production schedules.

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.

• Manages creation, revision and development of documents, including the change control process, to achieve clear, concise and accurate instructional documents.
• Provides editorial support and ensures quality of all document content; focuses on clarity, accuracy and consistency, while maintaining adherence to proper formats, regulatory requirements and company procedures and guidelines.
• Initiate and manage document reviews and revision to achieve clear, concise, and accurate instructional documents. 
• Procure and distribute templates from Document Control for the generation of new documents.
• Works and collaborates cross-functionally with other departments and sites to complete tasks and overall project timelines.
• Identifies continuous improvement opportunities within the organization and effectively sees them through completion.
• Ensure all work is performed and documented in accordance with cGMP requirements and existing company policies and procedures, as well as cGMP requirements.
• Perform tasks with a minimal error rate.
• Perform any other tasks/duties as assigned by management.

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.
• 0-1 year of experience in manufacturing, inspection, packaging, document control, quality control and/or project management in a GMP setting preferred.
• Strong computer and digital literacy including Microsoft Word and Excel products, required.
• Must be able to work independently, recognizing what needs to be done and accomplishing it with minimal supervision.
• Proven mathematical skills including addition, subtraction, multiplication, division, calculation of averages and percentages.
• Excellent organizational, time management, interpersonal and communication skills (oral and written).
• Must be adaptable and able to switch priorities as needed.
• 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 consider the viewpoints of others.
• 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, respirators, and protective gloves as required.  PPE and Respirators are essential for the health and safety of employees.
• Employee must be able to occasionally lift and/or move up to 50 pounds.

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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