Quality Assurance Specialist I

This position will report to the Quality Manager.

About the role

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.

Why join us

At Leiters Health, we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

• Innovative Culture: Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
• Meaningful Work: Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-Edge Technology: Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
• Collaborative Environment: Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

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.
• Support or perform internal audits.
• Support external regulatory or customer audits.
• Support or perform 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.

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.

Schedule

Monday–Friday, 1st Shift (8:30 AM – 5:00 PM).