Specialist, Quality

Job 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

• off shift and weekend support as needed

Preferred Experience and Skills:

• Familiarity with vaccine and/or pharmaceutical processing

• Aseptic gowning

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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