Client is hiring a 1st shift QA Specialist 2 with previous experience working with quality systems having oversight of cGMP production operations including experience with some or all of batch release, SAP and batch record review. This is a 40 hour per week contract role.
location: Cambridge, Massachusetts
job type: Contract
salary: $60.00 - 62.22 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Provide on the floor support to Manufacturing activities.
- Perform review of the manufacturing batch records for completeness and compliance with cGMPs as per regulatory requirements and internal procedures.
- Working knowledge and/or ownership of the following quality systems: Change Control, CAPAs, Deviations, and Self inspection auditing, QA reporting and approval of GMP documentation.
- Review and approve Standard Operating Procedures, logbooks and QC data.
- Support batch release of drug substance including compilation of documentation, as necessary.
qualifications:
Required:
- HS Diploma or equivalent and 8+ years of experience in a cGMP environment OR associate degree and 6+ years of experience in a cGMP environment OR bachelor's degree and 4+ years of experience in a cGMP environment.
- Previous experience working with quality systems having oversight of cGMP production operations including some or all of the following: batch release, SAP, batch record review.
- Bachelor of Science or Bachelor of Arts degree in a scientific discipline.
- Demonstrated experience in regulatory inspection activities.
- Ability to work on multiple projects on a tight timeline.
- Ability to prioritize and the flexibility to adapt to changing priorities.
- Working knowledge of cGMPs and associated regulatory requirements for the manufacture, testing, and release of pharmaceutical/biopharmaceutical products for international markets.
- SAP knowledge.
- Experience working successfully both independently and in a team environment.
- Able to interact with peers, subordinates and senior personnel in multidisciplinary environments including engineering, facility operations, validation, production, and QC.
- Able to prioritize and decide appropriate course of action.
- Root cause analysis experience preferred.
- Vaccines experience a plus.
skills: Quality control, Quality Assurance, CAPA, 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.
