Quality Assurance Specialist III
This position will report to the QA Compliance and Document Control Manager. The Quality Specialist III evaluates, tracks, trends, and monitors the Quality Assurance activities in an outsourcing facility. The position is responsible for final release review of batches including assessing and identifying trends to improve release processes. The position will support document control functions within Master Control. 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. The Quality Specialist III will also provide audit support as it relates to document control activities.
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 completed batch records and other relevant information to ensure procedures were followed, product tests performed appropriately and acceptance criteria met.
- Assist with monitoring the FMS system and generating FMS weekly report.
- 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.
- Gather information from multiple departments for trending and presentation to management.
- Support internal and external audits from a document control perspective.
- 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.
- Assist with managing the document control system to ensure the integrity and accessibility of documents.
- Assist with implementing corrective actions related to document control findings from audits.
- Create and revise controlled documents, including but not limited to, SOPs, batch records, deviations, CAPAs, and change control.
- Write deviations as necessary.
- Assist with training of staff on document control processes and systems.
- Other duties as assigned.
Supervisory Responsibilities:
Experience and Necessary Skills:
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).
3 or more years of relevant experience.
- Must pass English Competency Test
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
Shift: Monday-Friday
Timeline: We will be accepting applications on an ongoing basis until position is filled.
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.
*Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
