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Quality Assurance Batch Approval Specialist

Company: Pine Pharmaceuticals
Location: Tonawanda
Posted on: May 11, 2022

Job Description:

Job DescriptionSalary: $20-$22/hr DOEAbout UsPine is a family-owned and operated pharmaceutical company located in Tonawanda, NY along the beautiful Niagara River in the scenic Riverwalk business park. Our team is growing dramatically to meet the tremendous demand for sterile compounded drugs used by physicians every day across the country. Driven by teamwork, Pine is a prominent leader in the 503B outsourcing space, where we continue to innovate. What it's like to work here Pine was founded on a culture of caring, and not just about the specialty coffees available on-campus! At Pine, our employees care about each other, about our community, and about the patient who will ultimately receive the drugs we are responsible for compounding every day. There are a lot of perks working for Pine, including regularly catered lunches, employee appreciation programs, generous discretionary bi-annual profit sharing, healthy work-life balance, and much more! Above all else, Pine Pharmaceuticals is a family-owned and operated company, and employees are treated just like that. Family!Job Description:Perform a timely and efficient cGMP and quality review of batch record documentation to ensure prompt batch disposition and release, including raw data, batch production records, and test results to confirm accuracy and completeness. Includes functions to move product through ERP system. Job duties include the review and/or approval of required documentation in a cGMP 503B outsourcing facility, ensuring compliance to regulations, policies, and procedures. Requires multi- departmental communication to quickly and effectively resolve batch record documentation related issues, to ensure finished goods are released in a timely manner. Candidate will be expected to manage multiple tasks and adjust priorities based on supply needs. Primary Responsibilities: Batch production record review and batch approval to include: Step by step documentation review for completeness/accuracy of batch records Verification of all audit logs Review of batch-associated Non-conformances and Quality Events for status prior to batch release Verification of all required documentation through ERP system Review of release specifications for conformance Identification and routing of paperwork for corrections in cases of missing or incorrect documentation Routing of Approved batch records and product to proper location for distribution Triage workflow to ensure first in-first out release of finished product according to distribution needs. Work collaboratively with company Regulatory Affairs personnel to ensure current understanding of all rules and regulations from applicable regulatory boards and committees (example: State Board of Pharmacy, FDA, USP guidelines and OSHA) Work collaboratively with the production department to ensure quality and compounding policies and procedures are kept current Other Responsibilities & Duties: - Collaboration in onboarding Electronic EBR procedures and processes - Good documentation review for records outside of batch records including but not limited to logbooksKnowledge Skills and Abilities:

  • Knowledge of laws and regulations regarding cGMP Human Drug Compounding
  • Possess a professional appearance, with excellent interpersonal communication skills including presentation skills, and multitask ability
  • Strong computer skills, knowledgeable with standard Microsoft Office suite, email, document scanning, and strong Excel and Word experience
    • Self-motivated and organized with minimum supervision
    • Knowledge and understanding of FDA cGMP, CFR Parts 210 and 211, USP Chapters / Monographs, and various State Board of pharmacy laws as they relate to the Human Drug Compounding. Experience Required:
      • Strong preference given to candidates with Pharmaceutical QA / QC experience , including knowledge and understanding of FDA cGMP, CFR Parts 210 and 211, USP Chapters / Monographs, and various State Board of pharmacy laws as they relate to the Human Drug Compounding Benefits: 401K w/company matchDiscretionary bi-annual profit sharingHealth insurance (eligible to enroll on first day of hire)Generous vacation/sick timePaid holidaysPositive work/life balancePeer recognition programLeadership developmentEmployee discount at our sister company, Pine Pharmacy

Keywords: Pine Pharmaceuticals, Tonawanda , Quality Assurance Batch Approval Specialist, Other , Tonawanda, New York

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