job summary: As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. Located in 100 countries, our longtime partner is known for being the world's largest producer of vaccines and for covering seven major therapeutic areas. To be a part of the science that is changing the world, apply now!
location: Framingham, Massachusetts
job type: Contract
salary: $21.37 - 25.14 per hour
work hours: 9 to 5
education: High School
responsibilities: Job Responsibilities
- The Manufacturing Specialist II uses expert knowledge of compliance and GXP manufacturing processes to manage investigation and improvement initiatives within manufacturing operations.
- Practices safe work habits and adheres to company safety procedures and guidelines.
- Participates on cross functional teams to drive investigation close outs, determine root cause and implement appropriate Corrective and Preventative Action.
- Utilizes manufacturing process knowledge and investigation skill sets to identify and resolve manufacturing issues, improve process operations and affect positive changes.
- Conducts document revisions and/or document management including batch production records, and manufacturing procedures.
- Works with manufacturing managers and supervisors to develop and maintain training materials and curricula on process operations, theory, and compliance.
- Performs training with staff on the floor, as needed.
- Organizes and participates on cross-functional continuous improvement teams with Engineering, Validation, Quality Assurance, Quality Control, Facilities, Metrology, and Manufacturing Technical Services.
- Works independently with minimal supervision and direction.
- Participates in determining objectives of assignment.
- Performs work that consistently requires independent decision making and exercise of independent judgement and discretion.
- Effectively utilizes Microsoft office applications.
- Creates and presents trending and metrics reports.
qualifications: Education & Qualifications
- High school diploma/GED or Biotech Certification with 5-7 years of experience in cGXP manufacturing environment, or Bachelor's degree with 3-5 years of experience.
- Demonstrated knowledge / understanding of biologics manufacturing.
- Knowledge and demonstrated understanding of GXP and how it applies to specific responsibilities and manufacturing operations.
- Technical Writing
- Deviation Investigations
- Corrective and Preventative Action Planning
- Document Change Requests
- Change Control Execution
skills: Quality control, Quality Assurance, GCP (Good Clinical Practice), GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.