Quality Assurance Specialist Position Available In Kennebec, Maine
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Job Description
Quality Assurance Specialist (part of Allegis Group) 3.5 3.5 out of 5 stars Winslow, ME 04901 This role focuses on coordinating and executing Quality Assurance activities related to manufacturing floor support, ensuring compliance with regulatory and internal quality standards. The Quality Assurance Specialist plays a vital role in daily operations, working closely with Manufacturing and Process Teams to uphold quality and regulatory requirements.
Key Responsibilities:
Provide hands-on quality floor support, monitoring active processes for statuses, issues, concerns, and issuance of cell banks. Act as the primary QA representative on cross-functional process teams, serving as a first responder to manufacturing activities. Investigate and resolve complex technical issues, applying problem-solving skills and leading root cause analysis in collaboration with investigation teams. Conduct QA reviews and approvals for controlled documents, including solution records, batch records, logbooks, and autoclave cycles, ensuring accuracy and compliance. Oversee change management documentation, deviations, investigations, and CAPA records, ensuring timely resolution and adherence to regulatory expectations. Draft, revise, and maintain QA documentation, aligning with evolving industry standards and internal procedures. Lead and contribute to QA projects, operating with minimal supervision while ensuring alignment with organizational goals. Provide guidance and support to Quality Assurance Associates, fostering collaboration and knowledge-sharing.
Minimum Qualifications:
Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, Engineering, or related field (preferred). Minimum of 3 years experience in a regulated industry (USDA, FDA, ISO, etc.), with direct involvement in Quality Assurance. Strong understanding and application of GMP principles, with up-to-date knowledge of global GMP drug manufacturing regulations. Ability to work in controlled/clean room environments, meeting gowning qualification requirement
Job Type:
Full-time Pay:
$30.00 – $40.00 per hour Expected hours: 40 per week
Schedule:
8 hour shift Day shift
Work Location:
In person
