The Quality Assurance (QA) Associate is a vital role responsible for supporting and executing the site's Quality Management System (QMS). You will provide independent quality oversight of manufacturing, packaging, testing, and distribution to ensure all operations remain in a state of control and compliant with global regulatory standards, including 21 CFR Parts 210/211 and EU GMPs
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Responsibilities:
Documentation & Compliance: Perform detailed reviews of batch production records (BPRs), lab data, and logbooks for accuracy and compliance with ALCOA+ principles.
Operational Oversight: Provide "on-the-floor" QA presence during manufacturing, equipment setup, and cleaning activities.
Quality Approvals: Exercise QA approval authority for GMP documents, investigations, and change controls.
Production Verification: Perform line clearances, in-process checks, and verify critical process parameters and material status labeling.
Investigation & Analysis: Initiate and document deviations, nonconformities, OOS/OOT events, and complaints.
Continuous Improvement: Support trending of quality metrics (CAPAs, EM data, batch failures) and participate in risk assessments like FMEA.
Process Enhancement: Identify opportunities to strengthen controls and support the implementation of QMS enhancements.
Working hours: 8:00 AM - 5:00 PM
Skills:
Technical Knowledge: Strong understanding of GMP principles adapted to the pharmaceutical industry.
Analytical Thinking: Robust problem-solving skills and the ability to perform risk assessments.
Communication & Detail: Exceptional attention to detail, organizational skills, and effective communication.
Software: Proficiency in Microsoft Office, particularly Word and Excel.
Collaboration: Ability to work effectively in a team environment and promote a culture of quality.
Education:
Bachelors
Experience:
1-4 years
Qualifications:
Education: Bachelor???s degree in Life Sciences or a related field.
Experience: Previous experience in cGMP and cGLP environments, ideally within the pharmaceutical industry.
Training: Familiarity with GMP and GLP standards and a commitment to continuous professional development in these areas.
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At Spherion, 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 Callcenter@spherion.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, Spherion 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).