Specialist, Quality Operations Environmental Monitoring

Job Description

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

At least 3 year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations. Evidence of good oral and written communication skills (i.e., effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills). Attention to detail, flexibility and an awareness of production and attendant quality control problems. Basic understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields. Ability to sit, stand and move within workspace for extended periods, ability to perform repetitive tasks including frequent hand to finger manipulations, grasping, pushing and pulling; ability to lift up to 50 pounds.

Position Description: Specialist, Quality Operations Environmental Monitoring

• Specific to Environmental and Utility Monitoring, the analyst will be responsible for maintaining the EM program to include the following:

• Collection and testing of qualified Utility systems including Clean Steam, WFI and compressed gases.

• Execute environmental sampling of Classified Areas including active air sampling, surface sampling and non-viable air sampling.

• Provide data entry, review and approval as required.

• Provide summaries of test results to appropriate personnel as needed.

• Compile and evaluate environmental data for adverse trends.

• Directly support Performance Qualification activities.

• Perform routine monitoring of Personnel. - Compile and author Annual Reviews.

• Author and summarize Re-qualification, Performance Qualification, and Special Study protocols.

• Perform monthly and weekly sample accountability.

• Submit GLIMS sample rejections. - Equipment Calibration and Management

• Filing data sheets and document control of logbooks - Other duties requested by Management.

In addition, the candidate selected for the Environmental Monitoring (EM) position will be responsible for reading EM Plates, TOC analysis, Conductivity, Biological Indicators, KTA LAL, Bioburden, Growth Promotion, Micro-IDs, Gas Testing, LIMS, SAP, QN initiations and investigations, Trackwise, Change Controls, assisting with audits as an SME, writing and closing QN and QSAT CAPAs, with GMP experience.

Shift: Available for shift work, 4 - 10hr shifts (Wed-Sat) 4:00pm - 2:30am

Position Qualifications:

Education Minimum Requirement:

• Bachelor Degree of Science in Biology, Microbiology, Chemistry, or similar field of study.

Required Experience and Skills:

• At least 3 years of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations.

• Evidence of good oral and written communication skills (i.e.,, effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills).

• Attention to detail, flexibility and an awareness of production and attendant quality control problems.

• Strong understanding of GMPs and of regulatory requirements as they apply to the vaccine, sterile pharmaceutical or related fields.

• Ability to sit, stand and move within work space for extended periods,

• Ability to perform repetitive tasks including frequent hand to finger manipulations, grasping pushing and pulling;

• Ability to lift up to 50 pounds.

​Preferred Experience and Skills:

• Quality Control, Quality Assurance and/or cGMP experience.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for op