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location: Northborough, Massachusetts
job type: Contract
salary: $45.00 - 47.04 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Performing finished product disposition in accordance with company's SOP's, in-house product specifications and market regulations
- Reviewing and approving validation protocols and change controls
- Authoring, revising and reviewing SOP's through Veeva System
- Utilizing Veeva to complete investigation of deviations, CAPAs and Change Controls
- Supporting compliance walkthroughs, Participate in internal audits
- Participate in QA audit readiness program as well as assist and participate in external audits and regulatory inspections
- Interpreting complex, explicit documentation for new and current procedures and FDA enforcement actions/trends
- Completing analysis, identifying issues and providing recommendations for compliance improvements
- Completing Quality Events in Veeva
- Development and training of new staff as needed
- Participate in specialized projects both within Quality and cross-functionally
- Perform all aspects of Quality Disposition as it pertains to release activities that will include, but not limited to the disposition of raw materials and final packaging/component lots
- Support additional areas of Quality Disposition including Rejected, Quality Hold and Non-Conforming Materials
- Effectively demonstrates an understanding of GMPs & how it applies to specific responsibilities
- Maintaining material master data in ERP system
- Following accurate oral & written procedures in performing QA tasks
- Staying up-to-date on training of all procedures
- Routinely and safely handle high value product vials in various stages of packaging completion
- Adhering to company's safety procedures and guidelines
- Participate in Lean initiatives to improve Quality processes
- Participate in the QA consistency meetings to support continuous improvement efforts
- Support the QA on the floor initiatives which includes; attending daily capacity management and +QDCI meetings and assisting customers with resolution of issues in real time
- Effectively interact on a cross functional basis providing QA support at the area level and escalate any issues to Management in a timely fashion
- Ensure that department goals are achieved and on time Quality product is released through execution of primary role in area of oversight (Batch Record Review, Deviation Management and/or Lot Disposition, etc.)
- Comply with the requirements of company's health and safety program.
qualifications:
- Education: Bachelor's in Chemistry or Biology highly preferred but open to a BA in other sciences
- Must-Have Experience with: SAP, GMP, industry experience in quality control/manufacturing
- Preferred Experience: VEEVA
- Work Experience: minimum 4-5 (academia or industry)
skills: Quality control, SOP, Quality Assurance, CAPA, Biology, Chemistry, 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.
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 health, an incentive and recognition program, and 401K contribution (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.
