Manufacturing Specialist II
68 New York Ave, USMA0110 Framingham, MA
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 safety procedures and guidelines.
- Participates on cross functional teams to drive investigation close outs, determine root cause and implement appropriate Corrective and Presentative 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.
* Key Responsibilities may differ among employees with same job title and may change over time in accordance with business needs.
- Technical Writing
- Deviation Investigations
- Corrective and Preventative Action Planning
- Document Change Requests
- Change Control Execution
- 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.
- Excellent written and oral English language skills.
Kaztronix is an equal opportunity employer and does not discriminate on the basis of race, color, national origin, sex, age, religion, disability, veteran status or any other consideration made unlawful by federal, state or local laws.In addition, all human resource actions in such areas as compensation, employee benefits, transfers, layoffs, training and development are to be administered objectively, without regard to race, color, religion, age, sex, national origin, disability, veteran status or any other consideration made unlawful by federal, state or local laws.