Compliance Associate I

Responsibilities

• Perform detailed Quality Assurance review on executed manufacturing batch records for commercial and development products
• Conduct batch record compilation, maintenance, and error correction in coordination with various departments
• Perform investigation searches on executed batch records to ensure deviations are identified and assessed for closure
• Make entries into databases and spreadsheets to support production schedules and quality indicators
• Compile reviewed batch records into final complete sets for final QA release
• Manage released batch records and facilitate document scanning
• Prioritize workload to support timely product release and shipping schedules

Requirements

• High School diploma or equivalent required
• 3+ years of experience in a Quality Assurance role within the pharmaceutical or medical device industry
• Strong knowledge of cGMPs and regulatory documentation requirements
• Proficiency in MS Word, Excel, and Access
• Excellent troubleshooting, problem-solving, and organizational skills
• Ability to work independently and communicate effectively with employees at all levels

Preferred Qualifications

• Associate's degree in a technical subject
• Some college coursework in technical subjects

About the Company

Tolmar is a pharmaceutical company dedicated to positively impacting lives through ethical, compliant, and innovative healthcare solutions. We operate with a focus on being proactive, agile, and accountable, placing people at the heart of everything we do.