QA Specialist

Responsibilities

• Primary generation and review of supplier | contractor evaluation documentation, including supplier evaluations, questionnaires, and audit reports.
• Generation and review of quality agreements between suppliers and company.
• Review and approval of material specifications.
• Oversight for shipping and receiving activities.
• Current with regulatory requirements, industry trends, and best practices to ensure continuous compliance and quality improvement.
• Tracking of mitigations.
• Conduct internal audits and assessments to evaluate compliance with SOPs, GMP, GLP, and other quality standards.
• Ability to manage multiple projects in a fast-paced environment.

Qualifications

• Degree required; degree preferred to be in a related Science (Chemistry, Biology, Biochemistry, Microbiology etc.)
• Minimum of 5 years of biopharma industry experience with increasing responsibilities in supplier quality management and/or supply chain quality.
• Experience with executing or providing oversight for supplier qualification activities for FDA/EMA regulated aseptic manufacturing facilities, preferred.
• General computer skills are evidenced by hands-on work with computerized Operations equipment (SAP); and reporting and data analysis software (Word, Excel, Visio, JMP, Minitab, etc.).

Contact our Recruiter:

For more information about the role and to express your interest, you can reach out to our recruiter, Julia, directly:

Email: jdarling@harbasolutions.com

Phone: (317) 863-0797

About Harba Solutions:

Harba Solutions is a leading scientific staffing firm operating across a range of scientific industries including pharmaceuticals, biotechnology, medical devices, contract research organizations, and agricultural sciences. With a substantial network of qualified scientific candidates and ongoing interactions with emerging talents, we specialize in effectively placing scientific professionals in roles encompassing laboratories, chemistry, biology, and quality-focused disciplines, to name a few. Backed by strategic investors, our core values of commitment, work ethic, team and self-ownership, craft mastery, and pursuit of success shape our mission. Explore the opportunities at Harba Solutions and become part of the evolution of scientific staffing.

Learn more about us:www.harbasolutions.com

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