Rachel Cole
@rachelcole
Quality Assurance professional delivering audit-ready documentation and regulatory compliance.
United StatesWhat I'm looking for
I’m a Quality Assurance and compliance-focused corporate professional with 8+ years of experience supporting documentation management, audit readiness, and administrative coordination in fast-paced biopharmaceutical environments. I’m recognized for precision and reliability, especially when it comes to keeping regulated documentation consistent, complete, and template-aligned.
In my current role as Corporate Quality Coordinator, I oversee corporate QA documentation, audits, and regulatory correspondence to ensure compliance with internal and FDA standards. I collaborate cross-functionally to improve workflows and reporting, maintain documentation accuracy and version control across regulated systems, and support label content verification and proofreading against global standards.
Earlier roles strengthened my operational compliance foundation through center-level quality leadership, internal audits, and CAPAs, including work as an Assistant Manager / Quality Assurance Specialist. I bring strong analytical problem solving, technical writing and reporting, and hands-on experience with tools like MasterControl, SAP, and SQL to deliver dependable quality support across multiple departments and projects.
Experience
Work history, roles, and key accomplishments
Corporate Quality Coordinator
Kedrion Biopharma
Dec 2022 - Present (3 years 6 months)
Oversaw corporate QA documentation, audits, and FDA/regulatory correspondence to maintain compliance with internal SOPs and labeling requirements. Partnered across teams to improve workflows, strengthen version control, and ensure documentation accuracy for audit readiness and issue resolution.
Reviewed MDE requests for accuracy, completeness, and consistency to ensure compliance with federal documentation standards. Streamlined documentation review processes with internal teams to reduce the documentation cycle time.
Oversaw operational compliance in the donor center, ensuring alignment with FDA and company SOPs. Led day-to-day operations in the Center Manager’s absence and supported a smooth transition following the divestiture from KEDPlasma to Grifols USA.
Assistant Manager & QA Specialist
Kedplasma
May 2020 - Jan 2022 (1 year 8 months)
Supported center-level compliance by ensuring adherence to cGMP, DCOPs, and corporate SOPs. Assisted with internal audits and CAPA/document reviews to strengthen regulatory alignment, and advanced from QA Specialist to Assistant Manager during the acquisition transition.
Medical Screener
Immunotek Bio Centers LLC
Apr 2017 - May 2020 (3 years 1 month)
Conducted donor medical screenings and entered data to support regulatory documentation requirements. Maintained compliance and documentation accuracy during the acquisition by KEDPlasma, supporting a transition with zero audit findings.
Education
Degrees, certifications, and relevant coursework
Meridian Community College
2016 - 2020
Attended Meridian Community College in Meridian, Mississippi from 2016 to 2020.
Tech stack
Software and tools used professionally
Availability
Location
United StatesAuthorized to work in
Job categories
Skills
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