Quality Assurance Technician 2nd Shift

Quality Assurance Technician

This position reports to the Quality Assurance Supervisor. The Quality Assurance Technician is responsible for reviewing, approving and storing appropriately evidence of quality & validation activities in a 503B Outsourcing facility. The position is responsible for assuring that the drug product(s) produced or planned have the safety, identity, quality, purity & testing evidence required for compliance.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – 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.

Who We're Looking For:

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions:

• Evaluate and disposition documentation and labeling relative to specifications.
• Evaluate and write validation protocols including commercial batch and stability test methods as well as sterilization techniques for consumables, containers and finished drug products. Also, provide support to equipment validation and subsequent quality dispositioning.
• Review and approve executed formulation batch records and other relevant documentation to ensure procedures were followed and acceptance criteria met, as applicable.
• Evaluate, plan and review sampling instructions, specifications, test methods, quality control procedures, and standard operating procedures, as assigned.
• Review and retain all records associated with batch production, packaging, and labeling.
• Support deviations, CAPA’s, OOS results or complaints as appropriate.
• Work collaboratively with various staff members to support the manufacture of drug products in compliance with all regulations and company policies/procedures.
• 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.

Supervisory Requirements:

• No direct supervisory responsibilities.

Experience & Necessary Skills:

• Excellent interpersonal and communication skills, both verbal and written
• Ability to assume responsibility and act on own initiative
• Excellent self-management, organizational and planning skills. Detail oriented.
• Ability to adhere to strict deadlines and procedures
• Requires a high school diploma or its equivalent and at least 1-2 years of experience in the pharmaceutical field or in a related area. BS or BA degree (in a scientific discipline desired) preferred
• Familiar with standard concepts, practices, and procedures within the pharmaceutical field. Relies on experience and judgment to plan and accomplish goals.
• Performs a variety of tasks and works under general supervision.
• Hands- on approach with a "can-do" attitude
• Computer skills, including Microsoft Word, PowerPoint and Excel
• Knowledge and experience in Quality Assurance/Quality Control preferred
• Able to lift up to 20 lbs and stand for extended periods when required
• Certification of recent (less than one year) eye exam with minimum 20/30 vision