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Quaility Assurance Senior Associate
2 months ago
HERE’S THE JOB DESCRIPTION:
Title: Quality Assurance Senior Associate #13120
Pay Rate: up to $34.00/hr
Location: West Greenwich, RI 02817
Length: 1 year contract + possible extension
***This position works a rotating shift schedule, Week 1: Monday, Tuesday, Friday, Saturday Week 2: Sunday, Wednesday, Thursday, ~12 hours per day 6:45 AM – 7:00 PM ***
Job Summary:
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.
Top Must Have Skills:
- Quality/Manufacturing experience in Biotech/Pharma
- Decision making experience
- Accountability and proactiveness
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.
- Ensure that deviations from established procedures are investigated and 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
Day to Day Tasks:
- Closing executing batch records
- Reviewing logbooks, area documentation from manufacturing and other support teams
- Provide purposeful presence for manufacturing, facilities, engineering, and other QA groups
- Accountable to area of oversight
- Follow defined procedures
- Provide guidance for good documentation practices to staff executing processes
Preferred Qualifications:
- Bachelor’s Degree & 4 year of Quality/Manufacturing experience
- cGMP Experience
- Excellent written and verbal communication skills
Experience with decision making
