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This role requires employees to be fully vaccinated against COVID-19 as a condition of employment.
location: North Billerica, Massachusetts
job type: Permanent
salary: $100,000 - 160,000 per year
work hours: 9 to 5
education: Bachelors
responsibilities:
Provide functional and technical management of Quality Engineering and Release teams to ensure goals and objectives are met for product quality and are in compliance with all applicable regulations. Supports the Technical Operations Organization to drive compliance and continuous improvement initiatives to ensure product continuity.
- Chair the Investigational Review Board (IRB) and Change Control Review Board (CRB)
- Support Somerset Quality Operations for Change Control and Quality Event Investigations initiation and closure.
- Ensure staff members' activities and operations are in alignment with all internal policies and requirements, in compliance with all external regulatory requirements. Ensure a state of inspection readiness and meet business objectives. Manage the activities and performance of direct staff; this includes hiring, training, developing, addressing performance issues and evaluating performance.
- Provide technical direction, support and guidance for projects, qualifications and validations.
- Experience with Aseptic Processing and Terminal Sterilization processes preferred.
- Ensure investigations drive to root cause(s) utilizing appropriate tools (Fishbone, Cause Map analyses, etc.) ensuring investigation is through and effective CAPA(s) are implemented.
- Knowledge and utilization of Continuous Improvement tools (Value stream mapping, Process mapping, etc)
- Assist in monitoring and driving key performance quality metrics.
- Maintain, monitor the Quality on the Floor Program and Schedule and address issues as required to drive improvement of process and CGMP areas.
- Support commitments made (Observations and CAPA's) to regulatory agencies.
- Ensures coordination of batch record review and disposition decisions of finished product, active ingredients, raw materials, components and in-process materials consistent with company quality standards, business plans to meet ongoing continuity of product supply
- Represent QA Release at Production meetings to align with dynamic business needs
- Work with management and team to develop process strategies and mechanisms to identify continuous improvement opportunities, more efficient systems/processes, better compliance and increased departmental capability.
- Actively promotes safety rules and awareness. Demonstrates good safety practices at all times including the appropriate use of protective equipment. Reports and takes initiative to correct safety & environmental hazards.
qualifications:
- BS/BA degree in a relevant scientific discipline and a minimum of 7-10 years progressive Quality Engineering experience in the pharmaceutical industry, or equivalent.
- 3 to 5 years of direct supervisory experience
- Demonstrated proficiency and knowledge of cGMP, ICH, and other worldwide regulatory requirements
- May require handling of, or exposure to potentially hazardous chemical, radiological and or biological materials. Required to follow all safety procedures, and use personal and protective equipment provided.
- Must be detail oriented with the ability to multitask and respond to ever changing priorities.
- Excellent verbal, written and presentation skills at all levels both internally and externally, including regulatory bodies as well as customers.
skills: Quality Assurance, CAPA, ICH Regulations, 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.
EOEDisclaime For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.
