MSAT Coordinator

MSAT Coordinator

The MSAT Coordinator role reports to the MSAT Manager and provides administrative and operational support to the Manufacturing Science and Technology (MSAT) team, ensuring that all technical documentation, records, and data systems are organized, current, and compliant with cGMP requirements. This role coordinates the creation, review, and maintenance of process-related documents, including batch records, protocols, and technical reports, and ensures alignment across Manufacturing, Quality, and MSAT functions. The ideal candidate is detail-oriented, organized, and comfortable working with electronic document management systems and technical data and has strong technical writing skills with a solid understanding of GMP manufacturing principles.

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.

Essential Functions:

This description is intended to be illustrative of the major duties performed by the employee assigned to this position.

Maintain and update master and executed batch records, ensuring compliance with current Good Manufacturing Practices (cGMP) and internal procedures.

Assist in drafting and revising MSAT documents such as protocols, technical reports, and process summaries.

Coordinate document reviews and approvals from Manufacturing, Quality, and MSAT functions.

Support implementation of process changes by updating related documentation where necessary

Ensure accuracy and consistency of process data, forms, and reports used in production and technology transfer.

Participate in investigations and CAPAs by providing document history or technical data as requested.

Other duties as assigned.

Experience and Necessary Competencies:

Associates degree in a scientific or technical field or equivalent experience is required. Bachelors degree or equivalent experience is highly preferred.

2+ years of experience in a GMP-regulated environment (503B, 505B, or pharmaceutical manufacturing preferred).

Strong attention to detail with excellent organizational and document control skills.

Understanding of batch record structure, manufacturing process documentation, and GMP requirements (21 CFR Part 210/211).

Ability to create technical and professional documents.

Strong ability to work independently and to coordinate with cross-functional teams.

Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!

Proficient written, verbal and oral English communication skills are required.

Proficiency with Microsoft 365 tools including Outlook, Word, MS Project and Excel.

Proficiency with document management Systems (MasterControl, Doc Compliance, Trackwise, etc.)

Physical Requirements:

Ability to stand or sit for extended periods of time.

Ability to lift, push and pull up to 50 pounds periodically.

Benefits:

Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)

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

Timeline: We will be accepting applications on an ongoing basis until the 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.