Support the global raw materials quality assurance program at a leading biotechnology company, collaborating cross-functionally to ensure compliant supplier onboarding, change management, and reliable manufacturing disposition decisions.
location: Norwood, Massachusetts
job type: Contract
salary: $30 - 38 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Assist the material supplier management process for all raw material and consumable suppliers including onboarding and qualification activities.
- Support the supplier change notification process and ensure notifications are assessed for impact based on risk.
- Support Supplier Corrective Action Request (SCAR) process by issuing supplier complaints and drive for resolution and corrective actions.
- Support quality agreement execution including coordination of negotiations with suppliers, customers and or partners, documentation of those quality agreements, and tracking adherence to quality agreement requirements.
- Support raw material qualification program and management of raw materials used in clinical and commercial programs.
- Support the material onboarding process ensuring all relevant GxP regulations, guidelines, and company policies are followed and in compliance.
- Support change controls, corrective and preventative actions (CAPAs), and quality investigations involving raw materials by completing assigned actions.
- Review quality plans
- Support investigations to provide root cause analysis and ensure effective corrective actions are taken.
- Ensuring compliance, and drive improvement plans where needed.
- Follow all relevant GxP regulations, guidelines, and company policies to ensure compliance with regulatory and internal requirements.
- Execute tasks precisely as defined in internal guiding documents including but not limited to standard operating procedures (SOPs) and work instructions.
- Follow Good Documentation Practices and Data Integrity requirements to ensure data, documentation, and records are completed and maintained for use by the business and available to support audits or inspections.
qualifications:
Required:
- BA/BS in a scientific or engineering discipline
- 1-3 years of Quality Assurance experience in pharmaceutical / biotech industries.
- Demonstrated understanding of GxP regulations.
- 1-3 years of experience with change management.
skills: SOP Development, Good Manufacturing Practices (GMP), Corrective and Preventive Actions (CAPA), Quality Assurance (QA)
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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
