MCS Associate Quality Assurance Specialist
1 day ago
This role will provide operational quality assurance support to a clinical drug product packaging and labeling team. The successful candidate will be responsible for reviewing and approving printed clinical labels, inspecting finished clinical packs, calculating expiration dates, and reviewing batch records. Additionally, they will assist with generating and compiling quality data and reports, as well as reviewing procedures and initiating deviation reports. There is potential for role expansion into support of product distribution functions.
Key Responsibilities:
• Review and approve printed clinical labels to ensure accuracy and compliance with regulatory requirements.
• Inspect finished clinical packs to ensure they meet quality and regulatory standards.
• Calculate expiration dates for clinical products and review batch records to ensure accuracy and completeness.
• Assist with generating and compiling quality data and reports, including lot track/trace and deviation reports.
• Review procedures and initiate deviation reports as needed.
• Collaborate with the team to ensure quality and regulatory compliance in a clinical drug product packaging and labeling facility.
Requirements:
• 5 years of quality assurance experience in the biotech industry, with a focus on GMP compliance.
• Direct GMP experience in biotech or pharma industry or related educational program (Biotech Program).
• Excellent communication skills and ability to work effectively on diverse teams.
• Ability to problem solve and exercise complex decision making using the scientific method.
Preferred Qualifications:
• Proficiency in SAP and MES for batch record review and sampling documentation.
• Strong attention to detail and excellent communication skills.
• Values continuous improvement and proactively identifies areas for operational efficiency.
Compensation and Benefits:
The pay rate range for this position is competitive and may vary based on several factors, including but not limited to, a candidate's qualifications, skills, competencies, experience, location, and end client requirements. Medical, dental, vision, PTO benefits, and ancillaries may be available for eligible Aditi Consulting employees and vary based on the plan options selected by the employee.
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