Environmental Monitoring Quality Specialist

Job Description

Position Description:

Environmental Monitoring Quality Specialist

The Environmental Monitoring Quality Specialist will become knowledgeable in Federal and other regulatory agency requirements and GMPs to assure that all areas operate in a state of compliance and will train on and gain competency in their responsibilities for assigned End to End. 

Responsibilities

• Become trained in the company's Quality SOPs, production SOPs as needed, SAP, and GLIMS functions as required by Environmental Monitoring Quality Specialists

• Learn and adhere to current Good Manufacturing Practices (cGMPs), the manufacturing process, the company's Quality Systems, and safety procedures

• Monitor environmental performance against specifications within classified areas

• Provide environmental support to manufacturing and testing areas as needed

• Quality review/approval of new and updated SOPs and Controlled Job Aids and ensures compliance with departmental procedures

• Actively participate in the Tier process to inform, escalate, collaborate across teams, and share and best practices

• Collaborate with IPT (Integrated Production Team) members in the identification and implementation of continuous improvement initiatives and action plans

• Aid in investigations into environmental excursions

• Aid in and support CAPA ( Corrective Action and Preventive Action) development and participates in continuous improvement initiatives

• Author environmental project protocols and reports

• Aid and participate in aseptic process simulations

• Assist with training of incoming and existing personnel

• Cross train to support other functional quality areas including but not limited to environmental monitoring support and deviation management

• Actively participate within and provides support with internal audits and regulatory inspections

Position Qualifications:

Education Minimum Requirement:

• Bachelor degree in Microbiology or Biology is preferred | Candidates with BS in Chemistry, Engineering, Pharmacy, or equivalent will be considered with relevant experience in environmental monitoring, laboratory operations, or sterile/vaccine production setting

Required Experience and Skills:

• Minimum one year of relevant post-degree work experience in Environmental Monitoring, Aseptic Manufacturing or Microbiological Laboratory Operations

• Evidence of good verbal 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

Preferred Experience and Skills:

• Familiarity with vaccine and/or pharmaceutical processing

• Aseptic gowning

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 open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

VETJOBS

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to e