- Performs audits necessary to ensure the compliance of manufacturing procedures to in-house specifications and government regulation.
- Establishes auditing requirements, quality standards and test methods in accordance with FDA and GMP requirements.
location: Framingham, Massachusetts
job type: Contract
salary: $29.27 - 34.44 per hour
work hours: 9 to 5
- Conducts internal audits of manufacturing processes to ensure compliance.
- Conducts review of testing results.
- Reviews document and completes inspection of returned goods.
- May be involved with establishing compliance requirements for the methodology transfer from Research to Quality Control.
- Interprets complex, explicit documentation to ensure quality standards and compliance.
- May provide training to new employees.
- Works under only very general supervision.
- Work is reviewed for soundness of judgment and overall adequacy and accuracy.
- Contributes to the completion of organizational projects and goals.
- Represents organization on specific projects.
- Bachelor's Degree in a scientific field and 4-6 years experience in a Quality and /or other cGMP related field, or Master's Degree in a scientific field and 2 years' experience in above.
- 2 years of experience in a Quality role.
- Technical writing, SOP Design, GMP expertise, experience/familiarity with biologics manufacturing operations
- Knowledge in external agency regulations (FDA, EMA, etc.) ? Strong computer, verbal and written communication skills.
- Experience in quality systems.
- Experience in leading cross functional team.
- Experience with Trackwise or equivalent system.
- 3+ years experience in a Quality Assurance role.
- Experience in bio-pharmaceutical industry.
- Capable of analyzing trends and metrics that lead to improvement.
- Strong technical writing skills.
- Effective time management, attention to detail, organizational skills, teamwork and collaboration.
- Significant capability in problem solving methodology.
- Experience working in an environment of operational excellence.
- Experience training and developing employees.
- Experience participating in external agency inspections.
- Knowledge of regulatory enforcement trends.
skills: SOP, FDA, 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.