Senior Quality Assurance Associate

⚡ Position Title: Quality Assurance Senior Associate

📌 Work Location: Holly Springs, NC, 27540

📌 Assignment Duration: 1 Year (Possible Extension)

📌 Work Schedule: Shifting Work Schedule

📌 Work Arrangement: Fully Onsite

🧠 Position Summary

• The Senior Associate, Plant Quality Assurance (PQA), in an on-the-floor capacity, will work directly with plant manufacturing and support groups to support ongoing bulk drug substance manufacturing and new product introduction initiatives including development, clinical, and commercial operations. This role facilitates real-time decision-making to ensure adherence to GMP quality requirements.

📌 Qualifications & Experience

• High school or GED plus 4 years work experience, or Associate degree plus 2 years work experience, or Bachelor’s degree plus 6 months work experience, or Master’s degree.
• Strong cGMP and GDP behaviors.
• Experience in biotechnology and knowledge of processes within a cGMP manufacturing facility or other highly regulated environment.
• Technical understanding of upstream and or downstream manufacturing in biotechnology production operations.
• Proficient in Microsoft Office and knowledgeable in electronic systems such as EBR, MES, DeltaV, and Electronic Quality Systems.

💼 Key Responsibilities

• Provide quality oversight for new product introduction activities, including facilities, utilities, equipment, systems, and processes, ensuring alignment with Quality Systems. Responsibilities may include supporting commissioning, qualification, validation activities, and new document creation.
• Deliver ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and applicable regulations.
• Ensure facilities, equipment, materials, processes, and procedures comply with regulations related to GMP, GDP, Safety, and other quality controls.
• Drive closure and completion (including review and approval) of cGMP processes, procedures, documents, and records, such as deviations, investigations, CAPAs, change controls, and validations.
• Ensure production and testing records and results are complete, accurate, and documented according to procedures, GDP, and cGMP requirements.
• Oversee and provide guidance during on-the-floor analytical testing activities.
• Ensure changes with potential impact to product quality are assessed according to established procedures.
• Ensure deviations from procedures are properly investigated and documented per requirements.
• Alert senior management of quality, compliance, supply, and safety risks.
• Provide project management support to drive timely task completion and support system implementation strategies.
• Identify and implement continuous improvement opportunities within processes and systems.
• Support and represent PQA during audits and inspections and may directly interact with regulatory agencies during on-site inspections.