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Microbiology Quality Control Supervisor

Grand Rapids, MI

Posted: 10/10/2022 Division: Life Sciences Job Number: JN -102022-15608

Job Description

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Microbiology Quality Control Supervisor:
  • Title: Microbiology Quality Control Supervisor
  • Location: Grand Rapids, MI
  • Industry: Pharmaceutical
  • Salary: Based on Experience
  • Employment Type: Direct Placement
Position summary:
Support and manage quality systems as they relate to environmental control in an aseptic processing operation, and all other microbiology testing related to customer products and company operations. The responsibilities of this position require effective cross-functional interaction at all levels, working within and leading teams to ensure compliance and drive continuous improvement of environmental control and microbiology testing.

Essential Functions:
  • Manage day to day support of operations related to environmental monitoring and monitoring of critical utilities.
  • Manage day to day prioritization of routine, in-process, stability and finished product testing.
  • Lead training of all new employees and maintain all training documentation via current system.
  • Review EM trending data, quarterly, and annual summary reports.
  • Review process and testing documentation as needed to ensure complete and accurate records are maintained.
  • Support the EIR system and assist in any related Laboratory Investigations, CAPA s, or NCR s.
  • Establish and maintain good technique with regards to working in an aseptic environment.
  • Independently author or revise internal test methods and standard operating procedures.
  • Oversight of all equipment use and equipment calibration logs.
  • Assesses process/procedure changes proposed by others for potential impact on environmental monitoring/microbiology testing processes.
  • Participate in cross-functional meetings and training sessions with manufacturing operations.
  • Assist in the conduct of vendor audits as a microbiology subject matter expert, as needed.
  • Participate in client and regulatory audits as a microbiology subject matter expert, prepares documents for review and speaks to company processes and procedures to answer auditor questions.
  • Open to a flexible and fluid work environment.
  • Coordinate with contract testing laboratories and experts as needed.
  • Support Company s Core Values of Quality, Service, Collaboration, and Courage.
  • Support Agency, customer and vendor audits as needed.
  • Responsible for exhibiting professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company's policies and practices.
Work Experience and Skills:
  • Minimum of 5 years experience in a Microbiology laboratory supporting an aseptic manufacturing process
  • Knowledge of QA principles and procedures in a pharma, biopharma, and/or biotech manufacturing environment.
  • Strong written and verbal communication skills, ability to communicate effectively with management, staff, and regulatory agencies by exhibiting excellent interpersonal skills.
  • Ability to interpret and translate Quality standards to ensure effective implementation.
  • Portrays appropriate levels of integrity and professionalism.
  • Ability to complete tasks with accuracy and efficiency.
  • Ability to communicate effectively with management, staff, vendors, clients, and regulatory agencies.
  • Organized, self-motivated, individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
  • Ability to work well in a cross-functional team environment.
  • Proficiency in both written and verbal communication and presentations.
  • Consistently/Frequently see (vision), hear, ability to read and write, ability to interpret information, basic math, reading and writing in English.
  • Energetic, self-motivated, organized individual who is accustomed to working in a deadline focused, high-pressure entrepreneurial environment.
  • Results oriented and efficient.
  • Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
  • Ability to work closely with a diverse customer base (internally and externally).
  • Ability to work well in a cross-functional team environment.
  • Must have proficient computer skills in Microsoft Word, Excel and Outlook.
Education:
  • Bachelor s degree in Microbiology or a related field.
SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
EOE/ADA
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