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Baxter Lead Pharmacist, Quality Manager - 503B Compounding in Bloomington, Indiana

Lead Pharmacist, Quality Manager - 503B Compounding

Req # JR - 031443

Location Bloomington, Indiana

Job Category Quality Control

Date posted 12/10/2020

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Summary :

The Quality Assurance 503B Compounding Pharmacist is a member of the Quality Assurance Leadership Team reporting directly to the Quality Manager II, Proprietary Products Quality Oversight. He or she provides direct support to 503B Compounding Activities to ensure that finished products meet the required specifications by managing QA Associates and supporting staff Pharmacist who provide quality oversight in the manufacturing areas. The Quality Assurance 503B Compounding Pharmacist provides decision making and oversight to ensure compliance to all regulatory and state agency regulations and guidelines and to Baxter Standard Operating Procedures. This position fully supports and drives quality operations on the production floor and communicates effectively with production team members, multiple levels of management, other customer support departments and applicable state or federal regulatory authorities. The Quality Assurance 503B Compounding Pharmacist creates an environment where teamwork, productivity, safety, identity, strength, purity and quality (SISPQ) are reflected in the finished product.

Essential Duties and Responsibilities (these are primary responsibilities of the role and the incumbent will perform other duties as assigned) :

  • Provides guidance, support, direction, and leadership through positive interactions with all personnel during daily operations

  • Plans and schedules the work of Quality Associates. Ensures all Quality Associate oversight tasks are properly completed and documented

  • Provides oversight to Quality Associates, supervising quality and compliance in day-to-day operational activities. Ensures production operations, labeling materials, process materials, packaging and finished products meet required standards.

  • Develops, maintains, and regularly updates QA standard operating procedures, QA instructions, job aids, and department policy procedures. Ensures product compliance regulations are followed.

  • Accountable for employee compliance with local, state, and federal regulations, standard operating procedures (SOPs), quality assurance, good documentation practices (GDPs), and good manufacturing practices (GMPs)

  • Works closely with Production Supervision, Technical Services, and Engineering to ensure adequacy and appropriateness of parameters, product specifications, and overall cGMP compliance

  • Creates and performs quality review on Failure Investigation Reports for deviations and/or non-compliance issues that occur during production activities. Authors and directs corrective and preventative action responses

  • Reviews risk assessment results and ensures compliance

  • Supports change control activities/documentation such as validation change control documents, work orders, Hold requirements, etc.

  • Ensures Quality review of batch records and systems in order to achieve internal targets and commitments for batch release

  • Performs final release of production batch records

  • Collaborates with the complaints department and responds to complaints involving product and patient

  • Ensures compliance with licensing, and federal, state, local and company-specific regulations related to quality of product and employee safety

  • Leads staff pharmacists in keeping current with continuing education requirements and changes to sterile compounding requirements

  • Builds and fosters relationships with Pharmacy Boards, Pharmacy Associations, Academic institutions, and external customers to enhance strategic collaboration

  • Facilitates Board of Pharmacy correspondence, inspections, reporting and follow-up

  • Supports management on decisions and issues related to state board of pharmacy regulations, along with attending

  • Board meetings

  • Responsible for maintenance and re-certification requirements for NABP Accreditation

  • Works in collaboration with management team to prepare for internal and external audits. Assists with timely closure of audit observations

  • Represents Quality during client audits and state and regulatory inspections as needed. Provides information as necessary to auditors that establishes credibility and demonstrates compliance with cGMPs

  • Tracks and trends Quality data for review and reporting

  • Interviews, hires, trains, and evaluates Quality Associate personnel

  • Supports continued operational alignment through staff meetings and 1:1 check-ins

  • Assist with budget and forecast to achieve operational and financial targets

  • Supports and leads cross functional continuous improvement project teams utilizing Lean principles

Job Requirements (Education and Experience ):

  • Valid B.S. or Pharm D from an accredited School of Pharmacy

  • Minimum of 3 years experience in sterile compounding, with experience as Pharmacist in Charge

  • Registered pharmacist in Indiana in good standing with the Indiana Board of Pharmacy, multi-state licenses preferred. Knowledge of the requirements of individual states desired

  • Minimum of 5 years management experience within a customer facing operation

  • Experience with aseptic manufacturing processes

  • Computer proficiency in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: JDE, BPLM, Pilgrim, Trackwise, etc.)

Physical / Safety Requirements:

  • Must wear appropriate PPE as required for various manufacturing areas

  • Must be able to gown for aseptic areas.

  • Duties may require overtime work, including nights and weekends

  • Use of hands and fingers to manipulate office equipment is required

  • Position requires sitting for long hours, but may involve walking or standing for periods of time.

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Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to[email protected]and let us know the nature of your request along with your contact information.

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