Quality Control Specialist Iii, Microbiology

Quality Control Specialist III, Microbiology Position Profile

Position Background:

The Quality Control Specialist, Microbiology will work with their team to focus on QC Microbiology test methods and environmental monitoring. Responsible for maintaining testing/sampling schedules to support release activities, lead and manage projects and investigations as well as associated corrective actions. Develop and lead training

requirements for the department and site; this includes classroom training sessions. Cross functional support and collaboration with multiple departments and vendors is required. Design and implement continuous improvements for the laboratory.

Remote Work Designation: Not Remote

Major Accountabilities:

• In collaboration with manager, schedule and manage the daily activities of direct reports.

• Organize and plan testing and sampling to meet the requirements of the EM program.

• Independently and expertly perform testing and EM per SOPs and GLP/GMP guidelines.

• Provide expert level mentoring and ensure personnel in the lab are properly

trained and compliant with regulatory rules and requirements.

• Obtain and maintain status as qualified trainer on laboratory assays and EM.

• Independently and expertly ensure that all data results from the QC Microbiology

  lab are accurate and provide recommendations for remedies when challenges

  arise.

• Manage project flow and work with production schedule to ensure testing

  deadlines are met.

• Leads development, review, and approval of protocols, reports and SOPs.

• Lead projects of large and diverse scope and complexity collaborating with

  manager for projects as needed.

• Lead lab investigations and initiate corrective actions for investigations.

• Coordinate sampling and testing for all clinical and product development

  samples.

• Author trending reports and validation reports.

• Mentor and develop QC Microbiology analysts.

Special Competencies:

• Knowledge of regulatory documents frequently used to establish SOPs such as Annex 1, USP, etc.

• Assessment of microorganisms recovered and corrective actions.

• Demonstrated collaboration skills to support cross functional activities.

• Strong technical/analytical skills including summary reports, trend reports,

  protocols and validation activities.

• Working knowledge and application of USP test standards.

General Competencies:

• Able to communicate effectively in English, both verbally and in writing.

• Excellent communication and interpersonal skills.

• Possess a positive roll-up-the-sleeves attitude and optimistic outlook.

• Strong ability to work in a fast-paced team environment with fluctuating

  priorities, and collaborate effectively with others.

• Excellent organizational and time management skills with ability to set own

  priorities in a timely manner.

• High degree of flexibility and adaptability.

• Basic computer skills required, such as knowledge of MS Word, Excel, PowerPoint, and Outlook.

• Must be able to work as needed to meet tight deadlines and at peak periods.

• Self-motivated and organized critical thinker with solid interpersonal and

  business communication skills.

• Demonstrated ability to work in a cross functional team.

• Adheres to company and facility specific policies and procedures, including SOP,

  training and meeting requirements.

• Always observe safety precautions and regulations in all areas where duties are

  performed.

• Responsible for reporting all safety hazards and potential unsafe working

  conditions.

• Ensures Humacyte or other required trainings/certifications are up to date.

• Represents the organization in a positive and professional manner.

• Reports to work on time and as scheduled.

Qualifications:

• Requires a Bachelor’s degree in Microbiology, Biology, or other biological Science.

• 2 to 5 years of experience in Microbiology/Environment Monitoring in a GMP

bio/pharma facility.

• Strong background in environmental monitoring and microbiological test

  methods such as growth, promotion, bioburden, and sterility.

• Understand, review, and apply regulatory guidance from global agencies, as

  applicable.

• Experience in creating and revising SOPs.

• Draft and execute scientifically sound investigations, CAPAs, and protocols

  associated with test method validation/qualification.

• Must be able to perform gowning for cleanroom entry and regularly spend time in a cleanroom environment.

• Position may require working holidays, weekends, and/or overtime.

• Will be required to regularly sit, stand for prolonged periods of time, also may be

  required to lift/pull/move items up to 30 pounds.

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