What are the responsibilities and job description for the Quality Assurance Specialist position at SSi People?
Job Title: Quality Assurance Specialist
Location: Holly Springs, North Carolina (On-Site)
Job Summary: We are seeking a skilled professional to support quality oversight activities related to raw material inspection, sampling, testing, and Commissioning, Qualification & Validation (CQV) initiatives. Our team ensures adherence to cGMP regulations and collaborates cross-functionally to maintain the highest standards of quality within a fast-paced manufacturing environment.
Responsibilities
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy
Location: Holly Springs, North Carolina (On-Site)
Job Summary: We are seeking a skilled professional to support quality oversight activities related to raw material inspection, sampling, testing, and Commissioning, Qualification & Validation (CQV) initiatives. Our team ensures adherence to cGMP regulations and collaborates cross-functionally to maintain the highest standards of quality within a fast-paced manufacturing environment.
Responsibilities
- Oversee inspection, sampling, and testing of raw materials, including biobags, tubing, filters, chemicals, and related manufacturing components.
- Review batch records, inspection records, testing results, and GMP documentation for accuracy and compliance.
- Provide quality assurance oversight for Commissioning, Qualification, and Validation (CQV) activities in facilities, utilities, equipment, computerized systems, and manufacturing processes.
- Initiate and manage deviations, CAPAs, SOPs, controlled documents, and support continuous improvement and regulatory audit readiness.
- Bachelor's degree with 5 years of experience preferred, or an equivalent combination of education and experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
- Strong knowledge of GMP, GDP, quality systems, and regulatory requirements including FDA and EMA guidelines.
- Experience supporting Commissioning, Qualification, Validation (CQV), and/or Computer System Validation (CSV) activities.
- Demonstrated competencies in raw material inspection, sampling, testing, and quality assurance review activities, familiarity with Raman technology and material identification testing preferred.
By applying for this job, you agree to receive calls, AI-generated calls, text messages, or emails from SSi People and its affiliates, and contracted partners. Frequency varies for text messages. Message and data rates may apply. Carriers are not liable for delayed or undelivered messages. You can reply STOP to cancel and HELP for help. You can access our privacy policy here: SSi People Privacy Policy