Quality Assurance Compliance Specialist
ImmunoGen, Inc. is in search of a Quality Assurance Specialist (Technical Support). The candidate will provide support to the Norwood facility internal customers to ensure Batch Reviews and associated Quality Processes (i.e. deviations, CAPA, change control, protocols, etc…) are progressed in a compliant and timely manner and ensure cGMP compliance is maintained. The candidate will work with cross functional teams to identify and implement meaningful corrective actions arising from deviations, audit observations and investigations. The candidate will also provide support to ImmunoGen, Inc. Contract Manufacturing Organizations functioning as a Person–in-Plant as needed.
Job Duties and Responsibilities include:
- Develop technical (process) and quality systems expertise
- Schedule and co-ordinate Change Control Review Board meeting
- Generate metrics at the required frequency which drive accountability and delivery of targets
- Support continuos improvement of current systems, procedures and practices by constructively challenging the current state to ensure consistency across systems
- Engage with project managers to support CMO activities
- Review and approve Change Controls, CAPA, Investigations, OOS and Deviations
- Revise and approve procedures as required
- Review and approve Internal & CMO batch production records, and associated documentation
- Travel required up to approximately 25%
- Bachelor’s degree in life sciences required preferably Chemistry
- Minimum 6-8 years experience in Quality Assurance/Quality required; additional experience in manufacturing and validation preferred
- Working knowledge of electronic systems
- Ability to lead, manage and motivate cross-functional teams
- Excellent written and oral communication including accurate and legible documentation skills
- Experience in problem solving, root cause analysis, FMEA
- Experience working with CMO's; preferably Fill/Finish organizations and Mab production
- Ability to work in a fast-paced environment; team oriented; independent work skills and a strong work ethic and ability to handle multiple projects
ImmunoGen, Inc. offers an excellent salary and benefits package including 100% paid health and dental insurance, 401(k) and tuition assistance. Please send a detailed resume to: Human Resources Department, ImmunoGen, Inc., 830 Winter Street, Waltham, MA 02451: Fax: 781-895-0611; E-mail: email@example.com. Please reference the ad source in your response.
We are an Equal Opportunity Employer
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Founded in 1985, MassBio represents over 600 biotechnology companies, academic institutions, research hospitals, and service organizations involved in life sciences and health care, and works to advance policy and promote education, while providing member programs and events, industry information, and services.
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