QC Documentation and Compliance Coordinator
The QC Documentation and Compliance Coordinator at Confidential Client supports the Quality Control department by preparing and maintaining critical documentation, coordinating compliance activities, and assisting with investigations. This role ensures adherence to regulatory standards and facilitates communication across departments to maintain quality and compliance in pharmaceutical manufacturing processes.
About Careertakes
👉 Important disclosure: Careertakes is a third-party recruiting platform supporting this hiring process. If selected, you will be employed directly by our client, Scientific & QA.
Applicants for this role may also receive access to additional matched opportunities through the Careertakes platform.
Responsibilities
- Draft and revise Standard Operating Procedures (SOPs), work instructions, forms, and logs to support Quality Control documentation.
- Coordinate document reviews and approvals; follow up on outstanding comments to keep projects on schedule.
- Maintain controlled QC documentation and revision records per established procedures.
- Assist in preparing Laboratory Investigation Reports (LIRs), deviations, Out‑of‑Specification (OOS) reports, and CAPA documentation.
- Collect, organize, and archive laboratory records, analyst statements, calculations, and supporting evidence for investigations and audits.
- Track investigation status, assigned actions, and deadlines; prepare draft investigation summaries for technical review.
- Locate and summarize applicable United States Pharmacopeia (USP) monograph requirements for technical reviewers.
- Assist with preparation of 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 stakeholders.
- Follow up on assigned documentation and compliance activities to support timely closure.
- Perform other duties as assigned to support QC compliance and documentation programs.
Work Schedule
- 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; ability to prepare clear, accurate technical documents.
- Proficiency with Microsoft Word, Excel, Outlook, and Adobe Acrobat (or equivalent PDF tools).
- Strong organizational skills, attention to detail, and reliable follow-through.
- Ability to manage multiple priorities and work independently within assigned responsibilities.
- Must be legally authorized to work in the United States.
Preferred Qualifications
- Experience in laboratory, manufacturing, quality, or technical documentation (entry-level candidates with strong writing/organizational skills are considered).
- Experience in a Good Manufacturing Practice (GMP) environment (pharmaceuticals, dietary supplements, food, cosmetics).
- Hands-on experience preparing or revising SOPs, work instructions, or other controlled documents.
- Familiarity with investigations, deviations, OOS results, and CAPA processes.
- Familiarity with USP monographs and laboratory record-keeping best practices.
- Experience coordinating across Quality Control, Quality Assurance, Production, Warehouse, Purchasing, or Regulatory teams.
What We Offer
- Competitive compensation based on experience and qualifications.
- Medical, dental, and vision insurance.
- Company-paid life insurance; voluntary life and short‑term disability options.
- Health Savings Account (HSA) options (where eligible).
- 401(k) retirement savings plan with employer matching contributions.
- Access to earned wages before payday (ZayZoon or similar program).
- Paid vacation and company-observed holidays.
Location & Employment Details
- This position is located in Olive Branch, MS. Employment will be with a Confidential Client and adheres to applicable federal and state employment laws.
- The Confidential Client participates in E‑Verify to confirm employment eligibility.
- Background checks and drug screening may be required as part of the hiring process.
Equal Opportunity & Hiring Transparency
Careertakes and our client are Equal Opportunity Employers committed to building a diverse and inclusive workforce. We prohibit discrimination or harassment of any kind. To support a fair and efficient hiring process, AI tools may be used to assist with application review or resume screening. These tools do not replace human decision-making. Final hiring decisions are made by people.
If you have questions about how your data is used, please contact us directly.
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