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Quality Assurance Supervisor - Operations

Company: NorthStar Medical Radioisotopes, LLC
Location: Janesville
Posted on: November 11, 2019

Job Description:

Applicants must be able to work legally within the United States, and we currently do not offer H1B Visa sponsorship. Please, no 3rd party inquiries.
SUMMARYThe Quality Assurance (QA) Supervisor - Operations is responsible for providing oversight for Operations/Manufacturing to ensure day to day compliance with applicable domestic and international regulations and standards so that product distribution to the desired markets is realized. The QA Supervisor - Operations will be responsible for ensuring that cGMP compliant quality processes are maintained.
ESSENTIAL DUTIES AND RESPONSIBILITIESinclude the following, other duties may be assigned:

  • Direct and assist with the daily QA functions by maintaining internal QA and site systems to meet site needs while ensuring adherence to Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), Good Documentation Practice (GDP), and other regulatory requirements.
  • Direct and perform the review of documentation including but not limited to Procedures, Batch Production Records, Equipment Qualifications Protocols, Analytical Method Validation, Process Validation Protocols, and Nonconformity investigations related to materials, process, and products.
  • Assist in the development of QA plans by identifying critical control points and preventive measures, monitoring adherence to procedures, and implementing corrective actions and verification procedures.
  • Initiate, review, and approve change controls.
  • Assist with regulatory audits.
  • Ensure quality metrics are collected, reviewed, and actionable. Prepare quality documentation and reports by collecting, analyzing, and summarizing information and trends including production processes, environmental monitoring data, CAPA, Nonconformance, OOS data, and validation information. Report quality metrics to Senior Manager, Quality Assurance - Operations.
  • Perform Internal Audits, External Audits, and Data Audits, as assigned by Senior Manager, Quality Assurance - operations.
  • Support the resolution of product/assembly issues in Operations/Manufacturing through coordination of quality system investigations, recommending customer bulletins, etc.
  • Provide on-the-floor QA oversight of manufacturing operations.
  • Assist in document creation and review, including Standard Operating Procedures, protocols, batch production records, and reports.
  • Ensure direct reports remain current on their required training.
  • Perform other quality assurance functions as necessary, with appropriate training.
  • Effectively communicate safety and quality issues raised by customers or staff in a timely manner.
  • Support NorthStar's Quality System and Health & Safety Program by following policies and procedures.
    Ability and willingness to travel, both domestically and internationally, up to 20% of the time.
    QUALIFICATIONSTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
    EDUCATION and/or EXPERIENCEBachelor's Degree in Chemistry, Biology, Engineering or other related scientific discipline and five or more years of Quality Assurance experience within the pharmaceutical/medical device; or equivalent combination of education and experience. A minimum of two years of lead experience over Quality Professionals is required. Experience working directly with regulatory agencies, sound knowledge of applicable portions of agency guidance's, and regulations (21CFR Part 210/211/820). Experience with radiopharmaceuticals preferred.
    COMPUTER SKILLSProficient knowledge of Microsoft Office software programs, including Outlook, Word, Excel, and PowerPoint.
    SUPERVISORY RESPONSIBILITIESInterview, hire, and train employees; plan, assign, and direct work; appraise performance; reward and discipline employees; address complaints and resolve problems.
    OTHER QUALIFICATIONS
    • Ability to work long (> 8 hours) and unusual hours to include weekends and holidays
    • Basic knowledge of analytical, microbiology, and stability laboratory activities
    • Strong attention to detail
    • Excellent communication skills, verbal and written
    • Ability to work in a team environment, as well as independently
    • Ability to handle multiple projects simultaneously
    • Ability to work in a fast-paced environment
    • Adaptable to change in the work environment
    • Experience with Process Validation - writing protocol, reviewing protocol, executing protocol
    • Ability to read and interpret engineering Drawings
    • Knowledgeable in Auditing. Auditing Certification
    • Knowledgeable in Statistical Applications

Keywords: NorthStar Medical Radioisotopes, LLC, Janesville , Quality Assurance Supervisor - Operations, Other , Janesville, Wisconsin

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