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Description:
In this vital role will be responsible for PQA 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.
Responsibilities Include the Following:
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.
Additional Skills & Qualifications:
Bachelors Degree 4 year of Quality/Manufacturing experience
cGMP Experience
Excellent written and verbal communication skills
Schedule:
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 *
OT pay every sunday according to RI state law
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.
Diversity, Equity & Inclusion
At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:
- Hiring diverse talent
- Maintaining an inclusive environment through persistent self-reflection
- Building a culture of care, engagement, and recognition with clear outcomes
- Ensuring growth opportunities for our people
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.
