What are the responsibilities and job description for the Operations Document Coordinator position at Leiters Inc?

Job Description

Operations Document Coordinator

This position reports to the Visual Inspection, Labeling & Packaging (VILP) or Manufacturing Manager. The Operations Document Coordinator is responsible for performing Manufacturing, and VILP Batch Record (BR) initial review and assisting Manufacturing and VILP leadership in making the necessary BR corrections to facilitate the QA BR final review performed prior to product release. This position will also be responsible for conducting less complex investigations for any manufacturing / VILP discrepancies that may occur during product manufacturing and / or inspection, labelling and packaging. 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, manufacturing and VILP experience, attention to detail, and excellent communication with other functional areas.

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 :

Review executed batch records and other relevant information to ensure documentation meets the ALCOA principles : Attributable, Legible, Contemporaneous, Original, Accurate

Facilitates batch record corrections prior to the QA BR review team.

Assists with BR corrections identified by the QA Specialists during the QA BR review process.

Tracks and trends corrections by department and by employee to identify areas for improvement (employee retraining, BR instructions that may need to be clarified, etc.)

Conduct less complex investigations related to manufacturing and VILP discrepancies.

Other duties as assigned.

Supervisory Responsibilities :

None

Experience and Necessary Skills :

Bachelor’s degree (in a scientific discipline desired) or equivalent experience.

At least 2 years of experience in a cGMP environment, preferably in a pharmaceutical manufacturing organization.

Knowledge and experience with the cGMPs requirements, especially regarding Good Documentation Practices (GDP).

Detail oriented and able to identify potential adverse issues.

Excellent organization and documentation skills.

Proficient with computer skills, including Microsoft Word and Excel.

Proficient written, verbal and oral English communication skills.

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

Physical Requirements :

Ability to stand or sit for extended periods of time.

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

Ability to maintain a gowning qualification, if applicable.

Must have 20 / 20 near range vision and proficient color perception, with or without correction, if applicable.

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 7 : 30am-4pm, Monday-Friday 3 : 30pm-12am

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.

7 : 30am - 4 : 00pm Mon-Fri (1)

3 : 30pm - 12am Mon-Fri (1)

40 hrs / week

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