Manufacturing Investigator I

    • Job Tracking ID: 85430-286074
    • Job Location: Cambridge, MA
    • Job Level: Any
    • Level of Education: Any
    • Job Type: Full-Time/Regular
    • Date Updated: 07/09/2019
    • Years of Experience: Not Applicable
    • Starting Date: ASAP
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Job Description

Brammer Bio is a rapidly growing, dynamic gene therapy contract development and manufacturing organization that is seeking sharp individuals to bring the highest quality processes, products and testing to our clients. Our employees are committed to making a difference in our organization, for our client partners and the patients we serve. We are looking for top talent with proven competencies and strong character to join our team and help lead our organization into the future.

The Manufacturing Investigator I in this role will be part of a cohesive team responsible for Deviations and CAPAs for all phases of manufacturing. The Manufacturing Investigator I uses expert knowledge of cGMP regulations and project management to ensure manufacturing readiness. The incumbent will also support investigations and improvement initiatives within the manufacturing operations. Works independently with minimal supervision and direction. Performs work that consistently requires independent decision making and the exercise of independent judgment and discretion.

Key Duties

  • Support manufacturing corrective and preventative actions
  • Support manufacturing internal and external observations
  • Lead manufacturing investigations if needed
  • Support daily huddle meetings if needed
  • Practices and promotes safe work habits and adheres to safety procedures and guidelines
  • Utilizes manufacturing process knowledge and investigational skills to identify and resolve manufacturing issues and drive continuous improvement in process operations

Maintain and Improve Systems

  • Support and develop consistent manufacturing/quality standards and/or process for Deviations, and CAPAs in new Quality System
  • Conducts complex document revisions and/or document management including batch production records and manufacturing procedures
  • Performs training with staff for Deviations and CAPAs as needed
  • Supports cross-functional continuous improvement teams, with Engineering, Validation, Quality Assurance, Quality Control, Facilities, and Manufacturing Science and Technology
  • Supports cross-functional company goals for Site Metrics
  • Builds cross-functional relationships and enhances
  • Works cooperatively with others to meet group and organizational goals

Other Duties

  • Participates in initiatives to support, innovation and continuous improvement activities and improved compliance with quality procedures, policies and regulations.
  • Participate in client and planning meetings as requested

Experience and Skills

  • Ability to function in a fast paced, dynamic environment with multiple priorities simultaneously
  • Strong interpersonal and communication skills and the ability to work effectively with a wide range of constituencies in a diverse community.
  • Ability to make decisions and work with minimal to moderate supervision.
  • Able to provide effective written or verbal communication to peers, senior associates, and area management within their operational groups
  • Strong planning, organization and multitasking skills
  • Solid understanding of root cause analysis tools
  • Strong Leadership skills

EDUCATION AND QUALIFICATIONS:

  • Minimum of 1-5 years’ experience in pharmaceuticals manufacturing and/or quality.
  • Minimum of 0-5 years’ experience writing investigations
  • Strong interpersonal and communications skills; written and oral