QA Specialist I

Leiters Health • Englewood, CO

211d

About The Position

This description is intended to be illustrative of the major duties performed by the employee recruited to this position. Performs other duties as assigned. This position will report to the Quality Manager. The Quality Specialist evaluates, tracks, trends, and monitors the Quality Assurance activities in an outsourcing facility. The position is responsible for the assurance that the drug product has the safety, identity, strength, quality, and purity represented. The candidate should have an excellent understanding of cGMP requirements. The position requires an individual who works independently and in a team environment, experienced in cGMP requirements, quality assurance, attention to detail, and excellent communication with other functional areas and sites.

Requirements

• Knowledge and experience with the 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).

Responsibilities

• Evaluate completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately and acceptance criteria met.
• Release batches through ERP system.
• Assist with monitoring the FMS system and generating FMS weekly report.
• Draft, review or approve sampling instructions, quality assurance procedures, and standard operating procedures.
• Ensure that the required 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.
• Supporting or performing internal audits.
• Supporting external regulatory or customer audits.
• Supporting or performing 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 the systems involved in an outsourcing facility are in a state of control.
• Other duties as assigned to ensure appropriate quality practices.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Bachelor's degree