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:

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.

SUPERVISORY RESPONSIBILITIES

N/A

EXPERIENCE AND NECESSARY COMPETENCIES

Associates degree in a scientific or technical field or equivalent experience is required. Bachelor's 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. Must have 20/20 near range vision and proficient color perception, with or without correction, if applicable.

Benefits:

Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!) Flexible Spending & Health Savings Accounts (FSA & HSA) available Dental & Vision insurance 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

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. 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