In this vital role, will be responsible for PQA (Plant Quality Assurance) On the Floor in support of Manufacturing activities. This position requires working directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements and deviations.
location: West Greenwich, Rhode Island
job type: Contract
salary: $30.00 - 35.17 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Provide Quality oversight to ensure that operations products are manufactured, tested, stored, and distributed according to current applicable regulations.
- Ensure that facilities, equipment, materials, organization, processes, procedures and products follow cGMP practices and other applicable regulations.
- Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders, and other GMP documentation.
- Ensure that deviations from established procedures are documented per procedures.
- Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements.
- Alert management of quality, compliance, supply and safety risks.
- Complete required assigned training to permit execution of required tasks.
- Responsible for being in clean room space for majority of time on shift which includes gowning in and out of frocks and coveralls.
- Communicating and collaborating with the PQA shift to ensure required tasks are completed
qualifications:
- Bachelor's degree and 2 years of Quality/Manufacturing work experience
- Experience working in a cGMP environment
- Experience with decision making
- Experience with analytical testing and/or general compendia testing
- Experience working with batch records and other GMP documentation
- Knowledge of data integrity requirements
- Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)
- Experience collaborating within and across functional areas and demonstrated customer service focus
- Excellent written and verbal communication skills
- Ability to prioritize and navigate ambiguity, with minimal oversight, in a fast-paced environment
skills: GMP (Good Manufacturing Practice), 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.
