Quality Assurance Specialist Job Description Ensure customer satisfaction and cost savings by managing batch records in compliance with cGMP regulations and Quality Assurance Systems. Responsibilities + Review and integrate batch records into the Quality Assurance System. + Ensure records are complete, accurate, and meet specifications. + Create certificates of analysis and manufacturing. + Document and justify deviations and CAPAs. + Process alerts, deviations, customer complaints, CAPAs, Change Controls/Orders, and Annual Product Reviews. + Monitor and ensure timely completion of quality system actions. + Prepare investigations and respond to customer needs accurately and promptly. + Analyze monthly data to identify trends. + Implement and maintain lean standards and processes. + Use lean tools to eliminate waste and improve efficiency. + Institutionalize 5-S (Sort, Straighten, Shine, Standardize, Sustain). + Perform additional tasks as assigned. Essential Skills + Quality assurance + cGMP + GDP + Batch record management + CAPA + Batch record review + FDA compliance + Audit and inspection + QMS Additional Skills & Qualifications + Bachelor's degree in sciences discipline (Chemistry, Biology, Biochemistry, etc.) + 3+ years of industry quality experience within a GMP environment + Working knowledge of batch record reviewing + Experience in creating or maintaining COAs + Previous investigation and deviation documentation experience + Working experience with CAPAs + "Certified Quality Auditor" (CQA) Certification (preferred) Pay and Benefits The pay range for this position is $29.00 - $32.00 Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave) Workplace Type This is a fully onsite position in Eden Prairie,MN. Application Deadline This position will be accepting applications until Jan 1, 2025. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.