Job Description

Job Description

Job Description

The Pharmacist position will report directly to the Director of Corporate Quality & Regulatory Compliance and is responsible for applying clinical knowledge to appropriateness of formulation, processes, and procedures related to sterile pharmaceutical manufacturing and related activities in a 503B Outsourcing Facility. Quality Assurance Pharmacists work collaboratively with other pharmacists, technicians, and various staff members to manufacture sterile drug products to fill customer orders in compliance with all regulatory requirements and company policies and procedures.

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 positivelyimpactpatients ' lives.
• Professional Development: Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
• Cutting-EdgeTechnology: Work withstate-of-the-artfacilities 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.

• Review and verify formulation (compounding) activities and documentation performed by technicians and other support staff for completeness, accuracy, and adherence to cGMPs.
• Perform the final review and release of batches.
• Ensure compliance with all federal, state, and local regulations related to facility activities.
• Create/update product labels and determine appropriate label content per applicable regulations.
• Train manufacturing technicians to perform pharmaceutical calculations.
• Perform clinical product complaint and adverse drug event investigations.
• Write and/or review Standard Operating Procedures (SOPs) and deviations.
• Perform DEA recordkeeping and regulatory reporting activities to ensure compliance with all federal and state regulations.
• Participate in internal audits, regulatory inspections, and customer audits as necessary.
• Answer clinical questions from physicians, nurses, and other healthcare providers.
• Work collaboratively with members from various teams to achieve company goals.
• Other duties as assigned.

Supervisory Responsibilities:

• None

Experience and Necessary Skills:

• PharmD or equivalent education required.
• Ability to maintain Pharmacist Licensure in state of facility and additional states if applicable, as assigned.
• Experience in a GMP pharmacy compounding environment and/or pharmaceutical manufacturing facility preferred.
• Familiarity & Understanding of Sterile Manufacturing/Processing (USP testing, sterilization techniques, etc.) preferred
• Familiarity & Comprehension of regulations including DQSA, 21 CFR 211 and USP guidelines, as applicable.
• Ability to assume responsibility and act on own initiative
• Good self-management, organizational and planning skills
• Ability to adhere to strict deadlines and procedures
• Excellent reasoning and critical thinking skills
• Hands- on approach with a “can-do” attitude
• Good listener, but proactive in group discussions
• Proficient written, verbal and oral English communication skills are required.
• Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel is required.

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!)
• 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 

Compensation: In addition to base salary, the 2nd shift Pharmacist will be eligible for an additional 10% differential when working 2nd shift.

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.

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