Aptask Global Workforce (AGW) is seeking a Plant Quality Assurance Specialist for an Onsite position with a Global Biotechnology Company located in West Greenwich, RI. This is a 12+ month contract opportunity.
This vital role is responsible for providing Plant Quality Assurance (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. Please note, this position works a rotating 12-hour shift schedule (6:45 AM – 7:00 PM).
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
- Perform review and approval of cGMP processes, procedures, documents and records, including logbooks, batch records, attachments, and work orders
- 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
- Spend the majority of time on shift in a clean room space, which includes gowning in and out of frocks and coveralls
- Communicate and collaborate with the PQA shift to ensure required tasks are completed
Requirements:
- High school/GED and 4 years of work experience OR Associate's degree and 2 years of work experience OR Bachelor's degree and 6 months of work experience
- Experience working in a cGMP environment is a must
- Proficient in Microsoft Office (Outlook, Word, Excel, PowerPoint, MS Teams)
- Knowledge of Good Documentation Practices and data integrity requirements
- Experience collaborating within and across functional areas
- Excellent written and verbal communication skills
- Ability to prioritize and navigate ambiguity with minimal oversight in a fast-paced environment
Desired skills:
- Bachelor's degree and 2 years of Quality/Manufacturing work experience
- Experience with analytical testing and/or general compendia testing
- Experience working with batch records and other GMP documentation
Pay range: up to $28.85 per hour
Only candidates available and ready to work directly as Aptask Global Workforce (AGW) employees will be considered for this position.
If you have the described qualifications and are interested in this exciting opportunity, apply today!
Aptask Global Workforce (AGW)
ApTask Global Workforce (AGW) is a certified Minority and Veteran workforce solutions company. AGW delivers operational, clinical, lab and professional talent with a strong focus on healthcare and life sciences. The company supports clients with reliable staffing, program expertise and a commitment to quality, speed and consistent delivery.
Benefits of working with ApTask Global Workforce include:
- Medical
- Dental
- Vision
- Sick Pay (for applicable states/municipalities)
Our team stays close to the process and is here to guide you every step of the way. To learn more, please visit our website https://www.agwtalent.com/.
ApTask Global Workforce is an Equal Opportunity Employer. Candidates will receive consideration without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.
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