Job Description

Job Description

Johnson Service Group (JSG) is currently looking for a Compliance Specialist who will be responsible for owning and driving manufacturing compliance improvement through deviation resolution, applied root cause analysis and the application of CAPA to elevate safety, quality, cost, on-time delivery, and right first-time performance. This is a contract hire opportunity with a pharmaceutical company in Cambridge MA.

Pay: $45/hour

Skills/Description

• Ability to work in a clean room environment and comply with hygiene standards and use of clean room gowning.
• Bachelor's degree or equivalent experience and 3+ years of related experience.
• Biotech or Pharma industry required.
• Lead event investigations to adequately identify root cause and implement appropriate corrective and preventative actions to prevent reoccurrence,
• Lead CAPA investigations and at times manage the implementation of CAPA.
• Own manufacturing related change controls.
• Responsible for organizing data and preparing appropriate documentation, including presenting materials, for assigned projects.
• Recommending batch record and SOP improvements to reduce or eliminate GDP errors or correct root causes of deviations.
• Review production documentation and perform quality walk-throughs during manufacturing events.
• Participate in continuous improvement teams such as 5s, Gemba and the Client Production Systems (GPS).
• Provide training and guidance to team members on compliance-related matters to promote a culture of compliance throughout the organization.
• Lead team meetings and facilitate multidepartment discussions.
• Stay current with biopharmaceutical industry best practices and technologies.

Other duties as assigned

• Demonstrated knowledge of cGMP manufacturing with knowledge in manufacturing operations in downstream processing utilizing single use technology (SUT).

If you have the following characteristics, it would be a plus:

• SME or experienced with some or all of the following process equipment; homogenizers, tangential flow filtration (TFF), ultrafiltration/diafiltration (UFDF), Single use technology (SUT), buffer preparation and filtration.
• More advanced knowledge / proficiency with business software (i.e. Excel, Visio) and industry systems (LIMS, ERP, SAP).

Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with over 35 years of experience investing in people and companies. Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.

Company Description

Our people and culture make JSG a great place to work. JSG’s mission is to empower people, help our clients reach their goals, and hire motivated individuals.

Johnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with 40 years of experience investing in people and companies. We are always looking for great people to join our team—we want to see your success here at JSG! We can be found locally in more than 30 offices throughout the United States and Canada. JSG continues to work diligently to offer our clients and candidates world-class service and diversified offerings to fit their evolving needs.

We offer medical, dental, vision, life insurance options, 401(k), weekly pay, and more.

Johnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.

Company Description

Our people and culture make JSG a great place to work. JSG’s mission is to empower people, help our clients reach their goals, and hire motivated individuals.\r\n\r\nJohnson Service Group, Inc. (JSG) is a North American leader in the staffing and consulting services industry, with 40 years of experience investing in people and companies. We are always looking for great people to join our team—we want to see your success here at JSG! We can be found locally in more than 30 offices throughout the United States and Canada. JSG continues to work diligently to offer our clients and candidates world-class service and diversified offerings to fit their evolving needs.\r\n\r\nWe offer medical, dental, vision, life insurance options, 401(k), weekly pay, and more.\r\n\r\nJohnson Service Group (JSG) is an Equal Opportunity Employer. JSG provides equal employment opportunities to all applicants and employees without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, marital status, protected veteran status, or any other characteristic protected by law.