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Supervisor, Manufacturing Quality Assurance

4 months ago

Woodstock, United States Woodstock Sterile Solutions Full time
Job DescriptionJob Description

Woodstock Sterile Solutions is driven to positively impact global healthcare by providing our partners the best quality solutions to their sterile development and commercial needs. We are a growing organization with a bright future, and we are looking for motivated and experienced team members. We offer a comprehensive benefits and a generous Paid Time Off package. This position will be scheduled to work overnights, schedule to be determined, and is eligible for a 10% shift premium.

I. Position Overview:

The position is responsible for supporting the business by performing all quality related activities, as well as leading staff required to perform the activities. Key activities include lead QA staff, collect/analyze/report quality metrics, facilitate quarantines & Deviations in collaboration with Operations and Maintenance, resolve Quality issues, complete documentation, interact with customers and regulatory agencies including audits, support CAPA, and customer complaints.

II. Specific Duties, Activities, and Responsibilities:

  • Lead shift QA operations, including scheduling of QA Specialists and QA Associates, batch record review, document change control, training, Deviations, CAPA, and quality metrics.
  • Provide leadership, schedule, coordinate, direct, and review the activities and work assignments for QA Specialists and QA Associates in support of operations
  • Investigate, analyze and report key quality metrics, troubleshoot, resolve and document as required all quality issues that arise. Work collaboratively with Operations, Maintenance, MQA Management and the customer to assure compliance and on-time delivery.
  • Initiate, review, and complete documentation. Documentation includes Batch Records, SOPs, Work Instructions, Quarantines, Deviations, Validation Protocols, Customer Complaints, and Training Records.
  • Communicate Quality issues on a timely basis to MQA and Operations Management
  • Drive improvements in quality systems, business systems, and processes.
  • Develop staff to increase teamwork, individual capability and organizational flexibility.
  • Provide support for customer and regulatory audits
  • Maintain effectiveness of the Quality System components relevant to this position.
  • Identify, evaluate, and manage risk to ensure product quality. Communicate risk policies and processes throughout the organization.
  • Other duties as assigned.

III. Position Requirements:

Education or Equivalent:

  • Bachelor Science Degree or equivalent work experience; BS in science preferred

Experience:

  • 4-6 years of relevant work experience in the pharmaceutical industry

Knowledge/Skills Requirements:

  • Knowledge and experience in cGMP/FDA regulations. Experience in regulatory audits desired
  • Excellent verbal, written and interpersonal communication skills
  • Demonstrated ability to lead personnel
  • Demonstrated ability to handle multiple complex tasks and make timely/appropriate decisions with respect to product quality, compliance, and the customer
  • Strong math (statistical), root cause analysis, troubleshooting, and computer/software skills
  • Demonstrated experience n handling and responding to customer complaints and inquiries.
  • Ability to read, comprehend, execute and communicate English written SOP’s.
  • Demonstrated ability to read, write, and speak clear English.

Physical Requirements:

  • Frequent sitting, standing, walking, reading of written documents and use of computer monitor screen, reaching with hands and arms, talking, writing, listening
  • Occasional bending, grasping, carrying, stooping, kneeling, crouching
  • Frequent lifting and/or moving up to 10 pounds and occasional lifting and/or moving up to 30 pounds

Notice to Agency and Search Firm Representatives: Woodstock Sterile Solutions is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Woodstock Sterile Solutions employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Woodstock Sterile Solutions. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.