Job Description

Purpose

The Compounding Pharmacist will support the Associate Director of Operations and is responsible for supervising production operations of Compounded Sterile Preparations by implementing and maintaining Sterile Compounding policies/strategies in alignment with all regulatory authorities/guidance's and Hikma Corporate plans and policies. The Compounding Pharmacist will also evaluate any possible significant trends across the site and help drive continuous improvement efforts to adhere to regulatory requirements.

Key Accountabilities:

• Ensure adherence to batch records and aseptic techniques.
• Monitor Compounding personnel for compliance with gowning, behavior and aseptic technique.
• Conduct Investigations for manufacturing deviations.
• Execute CAPAs & Change Controls.
• Provide Aseptic Training
• Provide oversight of compounding and production activities, ensuring compliance with the FDA CFR, including cGMP and DEA regulations, as well as State Board of Pharmacy rules and regulations.
• Keep abreast of relevant guidance documents pertaining to 503B production.
• Monitor and communicate changes in regulations of all state and federal regulatory agencies.
• Assist in new 503B product development, including collaborating on labeling, stability study protocols, Master Batch Records, and product specification requirements ensuring compliance with all company procedures and federal and state laws, rules, and regulations.
• Attain all non-resident Pharmacist licenses within 1 year.

Primary Accountabilities:

• Assist the Associate Director of Compounding Operations ,daily oversight of compounding personnel and compounding operations in cleanroom environments. . Review, prepare and approve manufacturing deviations, master batch records and site change controls related to 503B Compounding Operations.
• Participate in the administration of Site Projects and New Product Launches to support 503B operations.
• Assist in the development and provision of GMP, Aseptic Behavior, and Quality Systems-related training to all applicable departments.
• Provide technical support in the interactions with and applications to state and federal regulatory bodies.
• Provide assistance in collection of documents and records regarding state licensing and renewals for state boards of pharmacy.
• Assist in writing, review and update of batch records, SOPs, and other cGMP documents.
• Maintain current pharmacist licenses in required states, as directed.
• Other duties as assigned.

Qualifications:

Minimum:

• Bachelor of Pharmacy or PharmD required.
• State of New Jersey license as a pharmacist is required. Multiple state licenses preferred or ability to obtain state license for the following (AL, AR, ID, KS, MI, MS, NV, NY, OH, OK, KY, VA).
• 503B Compounding experience and/or USP 797 knowledge and experience required.
• Knowledge of sterile compounding practices.
• Knowledge of associated standards and operating procedures in relation to cGMP.
• Knowledge of 503B practices, aseptic processes (gowning, garbing, gloving etc.)
• A broad perspective to organize objectives, both long-term and day-to-day activities

Experience:

Minimum:

• Pharmacist for a 503B outsourcing facility located in New Jersey preferred
• New Jersey licensure is required, as well as the ability to obtain multiple state licenses.
• Previous experience with 503B outsourcing, USP 797, and/or hospital IV compounding would be an advantage.

Skills:

• The ability to change direction and focus to meet shifting organizational and business demands.
• The ability to create and contribute to an environment that values people encourages trust, teamwork, and open communication, and provides participation, learning, feedback and recognition.
• The ability to effectively manage self, demonstrate integrity, be productive under pressure, and achieve development goals.
• The ability to take strategic objectives and accept accountability, motivate and influence others, think globally, and leverage diversity.
• The ability to manage multiple resources and be accurate and current with data and information.
• Ability to communicate technical information to non-technical personnel

What We Offer

• Clean climate-controlled working environment
• Annual performance bonus potential
• 401k employer match up to 6% of your contributions
• 23 vacation/personal days
• 11 paid Company holidays
• Generous healthcare benefits
• Employee discount program
• Wellbeing rewards programs
• Safety and Quality is a top organizational priority
• Career advancement/growth opportunities
• Tuition Reimbursement
• Maternity and Parental Leave

*Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to a specific plan or prog

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