Documentation Associate

3 months ago

Newtown, United States KVK Tech Full time
Job DescriptionJob Description

Department:

Quality Control

Job Title: Documentation Associate

FLSA Status: Non-Exempt

1. Role Purpose:

Maintain and ensure accuracy and consistency of data over the whole life-cycle. Ensure data is recorded exactly as intended and the same as originally recorded when retrieved. Ensure that data, irrespective of the format in which it is generated is recorded, processed, retained and used to ensure a complete, consistent and accurate record throughout the data lifecycle. Responsible to track compendial changes, implementation plans and deadlines; prepare, update and maintain methods and specifications; process change control requests; prepare documents for submission and maintain/validate spreadsheet and Empower calculations in a timely manner

2. Key Duties & Responsibilities:

  • Follow cGMP (current Good Manufacturing Practices), GLP (Good Laboratory Practices), 21CFR211.22, 21CFR211.28 and 21CFR211.170.
  • Follow the OSHA (Occupational Safety and Health Administration) and EPA (Environmental Protection Agency) safety regulations.
  • Follow all DEA (Drug Enforcement Agency) regulations per laboratory SOPs.
  • Prepare, maintain and revise analytical methods and specifications as required
  • Track and assist with implementation of compendial changes
  • Process change control requests as required.
  • Validate and maintain calculations in controlled Excel spreadsheets and Empower. Revalidate as required.
  • Perform other duties as required
  • Research and gather information in a timely manner.
  • Prepare, label, organize and maintain files.
  • Follow all SOPs.
  • Comply with FDA guidelines/Company Policies of Data Integrity
  • Other duties as assigned

3. Typical Supervisory Responsibility:

N/A

4. Education & Experience:

Associates degree in Science or related field from an accredited college or university preferred

5. Technical Competencies / Certifications / Licenses:

  • Pharmaceutical industry experience is preferred
  • Applicable knowledge of DEA regulations preferred
  • Good Math and computer skills including working knowledge of Word and Excel
  • Good verbal and written English
  • Good interpersonal and communication skills

6. Physical Demands & Work Environment:

While performing the duties of this job, the employee is required to walk, sit, and use hands to finger, handle or feel tools or controls, reach with hands and arms, balance, stoop, crouch, bend, talk and hear. The employee must lift and/or move up to 20 pounds. Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, and depth perception.

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