MQA - Component and Material Quality Specialist

Company: Pine Pharmaceuticals
Location: Tonawanda
Posted on: May 15, 2022

Job Description:

Job DescriptionSalary: $21.00/hr ABOUT USPine Pharmaceuticals 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 HEREPine 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 summary:Responsible for the oversight and qualification, in conjunction with MQA Manager and Director of Quality, of incoming raw materials, components, container/closure systems.

• Routine review and approval of all incoming lots of all raw materials, components, and container closure systems
  • Includes
    • Verification and review of content of COA, if available
    • Inspection of samples of incoming components to ensure critical quality attributes are present
    • Escalation of identified quality issues during incoming review/approval process
    • Assurance that quarantined materials are moved (physically and electronically) to approved warehouse
    • Routine sampling and facilitation of testing of raw materials and components/container closures to ensure quality certificates are accurate and quality measures are met
    • Oversight of component usage in Incoming Materials warehouse, to ensure:
      • Systems are in place to utilize approved raw materials and quarantine materials with identified or potential quality issues
      • First in/first out usage of raw materials
      • Adherence to procedures to allow for the correct and accurate issuance of materials to batches
      • Daily Manufacturing QA Functions:
        • Ensure all issued components are approved and meet the criteria for use
        • Verification of purity calculations for all APIs
        • Oversight of materials entering the cleanrooms, ensuring all stocked materials and components are approved for use and within date appropriate for use
        • Oversight of bulk mixing processes prior to filtration
        • Issuance of materials to BOMs as they are used
        • Bulk powder expiration date tracking
        • Evaluation of sourced materials for suitability in the event of shortages
        • Monitoring of trends associated with raw materials and escalation with investigation as needed
          • Includes but not limited to:
            • Issues with container/closure systems (e.g., intrinsic particulate matter, integrity, etc)
            • Issues with in-process components (e.g., faulty tubing, poorly crimping seals, etc)
            • Performance of re-usable component approval (i.e., Glassware runs, autoclave cycles)
            • Routine collaboration on cleaning validations, autoclave validations, etc
            • Routine process improvements and longitudinal projects including:
              • Development of component-specific check-in criteria to ensure quality requirements are met
              • Routine evaluation of standard operating procedures and policies governing the quality of raw materials, components, and container/closure systems
              • Collaboration with MQA Manager and Director of Quality on new material and new vendor qualification
                • Routine evaluation of vendor qualification (annual) Other Responsibilities & Duties:Longitudinal projects as required for routine process improvement measures.Qualifications, Skills & Abilities Required:
                  • Strict attention to detail
                    • Quality-based mindset
                    • Ability to identify and address deviations from policy and procedure
                    • Ability to perform risk-based assessment of events
                    • Strong communication skills and ability to advise operators for corrections when deviations are identified
                    • Excellent time management and ability to balance multiple responsibilities within the confines of one shift
                    • Ability to work independently and as a team
                    • Ability to identify process or procedure flaws and propose pathways to improvement (i.e., problem solving skills)Experience Required:
                      • Minimum of one year of aseptic manufacturing/cGMP experience
                      • Strong preference given to candidates with Pharmaceutical QA/QC mentoring experience, including knowledge and understanding of FDA cGMP, CFR Parts 210 and 211Physical Requirements:
                        • Ability to work in a cleanroom environment for the duration of an 8 hour shift
                        • Ability to perform high-level aseptic manufacturing gown/garb procedures
                        • Ability to stand and/or be mobile for up to 8 hoursBenefits:• 401K with company match• Discretionary bi-annual profit sharing• Health insurance (eligible to enroll on first day of hire)• Generous vacation/sick time• Paid holidays• Positive work/life balance• Peer recognition program• Leadership development• Employee discount at our sister company, Pine Pharmacy

Keywords: Pine Pharmaceuticals, Tonawanda , MQA - Component and Material Quality Specialist, Other , Tonawanda, New York