QC Documentation and Compliance Coordinator

Description

Position Summary

Natureplex, LLC, an established pharmaceutical manufacturer, is seeking a detail-oriented QC Documentation and Compliance Coordinator to support our Quality Control department. This position prepares and maintains documentation, supports investigations and compliance activities, and coordinates departmental follow-up. The primary focus is documentation and compliance support, not routine laboratory testing.

Essential Responsibilities

• Draft and revise Standard Operating Procedures (SOPs), work instructions, forms, and logs.
• Coordinate document reviews and approvals, including following up on outstanding comments.
• Maintain QC documentation and revision records per company procedures.
• Assist with preparing Laboratory Investigation Reports (LIRs), deviations, Out-of-Specification (OOS), and Corrective and Preventive Action (CAPA) documentation.
• Collect and organize laboratory records, analyst statements, calculations, and supporting information.
• Track investigation status, assigned actions, and deadlines.
• Prepare draft investigation summaries for technical review and approval.
• Locate and summarize applicable United States Pharmacopeia (USP) monograph requirements for technical review.
• Assist with preparing raw material and Active Pharmaceutical Ingredient (API) testing forms using approved methods.
• Coordinate documentation and information requests with Quality Assurance, Production, Warehouse, Purchasing, Regulatory, and other departments.
• Follow up on assigned documentation and compliance activities to support timely completion.
• Perform other duties as assigned.

• Monday through Friday, minimum 40 hours per week.
• Overtime as needed.
• Occasional Saturday work based on operational needs.

Required Qualifications

• Associate's or bachelor's degree in Chemistry, Biology, Pharmaceutical Sciences, Quality, or a related scientific field.
• Strong written and verbal communication skills, including the ability to prepare clear and accurate documents.
• Proficiency in Microsoft Word, Excel, Outlook, and Adobe Acrobat or comparable PDF software.
• Strong organizational skills, attention to detail, and follow-through on assignments.
• Ability to manage multiple priorities and work independently within assigned responsibilities.

• Experience in laboratory, manufacturing, quality, or technical documentation. Entry-level candidates with strong writing and organizational skills will be considered.
• Experience working in a Good Manufacturing Practice (GMP) environment, including pharmaceutical, dietary supplement, food, or cosmetic manufacturing.
• Experience preparing or revising SOPs, work instructions, or controlled documents.
• Familiarity with investigations, deviations, OOS results, and CAPA documentation.
• Familiarity with USP monographs, laboratory records, and controlled documentation.
• Experience coordinating activities with Quality Control, Quality Assurance, Production, Warehouse, Purchasing, or Regulatory personnel.

At Natureplex, LLC, we value our employees and offer a comprehensive benefits package designed to support their health, financial well-being, and work-life balance.

• Competitive compensation based on experience and qualifications
• Medical, dental, and vision insurance
• Company-paid life insurance
• Voluntary life and short-term disability insurance
• Health Savings Account (HSA) options for eligible employees
• 401(k) retirement savings plan with employer matching contributions
• Zay Zoon – access to earned wages before payday
• Paid vacation and company holidays

Natureplex, LLC is an Equal Opportunity Employer. We consider qualified applicants without regard to race, color, religion, sex, national origin, age, disability, veteran status, or any other status protected by applicable law.

Natureplex participates in E-Verify to confirm employment eligibility.