Quality Assurance Specialist

10 hours ago

Englewood, Colorado, United States Leiters Full time
Job Title: Quality Assurance Specialist I

Leiters is seeking a highly skilled Quality Assurance Specialist I to join our team. As a Quality Assurance Specialist I, you will be responsible for ensuring the quality and integrity of our products.

Key Responsibilities:
  • Evaluate batch records and other relevant information to ensure procedures were followed and product tests were performed appropriately.
  • Release batches through our ERP system.
  • Assist with monitoring the FMS system and generating FMS weekly reports.
  • Draft, review, or approve sampling instructions, quality assurance procedures, and standard operating procedures.
  • Ensure that initial and continuing training of personnel is carried out and adapted according to need.
  • Review and approve investigations of reprocessing/rework of products, analytical failures, and returns/salvages.
  • Classify, file, audit, receive, distribute, track, and maintain system of classified and unclassified company documents according to established procedures and standards for security and document organization.
  • Support internal and external audits.
  • Support supplier audits.
  • Gather information from multiple departments for trending and presentation to management.
  • Identify trends in the industry and recommend improvements.
  • Work with a team to ensure that systems involved in an outsourcing facility are in a state of control.
  • Perform other duties as assigned to ensure appropriate quality practices.
Requirements:
  • Knowledge and experience with cGMPs, preferably in a commercial compounding outsource facility.
  • Able to identify potential adverse issues.
  • Excellent organization and documentation skills.
  • Detail-oriented.
  • Computer skills, including Microsoft Word and Excel.
  • BS or BA degree (in a scientific discipline desired).
Benefits:
  • 100% employer-paid medical plan.
  • Dental & Vision insurance options including FSA & HSA.
  • Employer-paid Life Insurance & Employee Assistance Program.
  • Short Term & Long-Term Disability Insurance.
  • Up to 4% 401K Matching (100% vested on day one).
  • Generous Paid Time Off Options - vacation, sick, paid leave, and holidays.
  • $5,250 Annual Tuition Reimbursement after 6 months.
  • $1,000 Referral Bonus Program with no limit.
  • Eligible for annual bonus program.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

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