Lead Quality Specialist

Work Schedule

Environmental Conditions

Job Description

• Perform Quality Control inspections and reviews of operational activities, including receiving, shipping, and inventory management.
• Evaluate the suitability of components and products, including approval or rejection of incoming materials, in-process materials, and finished drug products.
• Ensure quality documentation—including protocols, procedures, and records—is accurate, up to date, and consistently applied.
• Provide oversight to ensure procedures and specifications are well-developed and effectively implemented.
• Lead process quality initiatives by monitoring trends, identifying root causes, and implementing corrective and preventive actions to minimize defects.
• Drive continuous improvement through the development and revision of Standard Operating Procedures (SOPs), management of change controls, and collection of compliance metrics.
• Collaborate with cross-functional managers to assess resource needs and ensure proper staff qualification in support of organizational goals.
• Conduct internal audits and site-level inspections to ensure compliance with regulatory and company standards.
• Perform supplier and vendor audits as required to maintain quality across the supply chain.
• Support and help maintain a competency-based training program to ensure team proficiency and regulatory compliance.

• Bachelor's Degree in Scientific/Technical field, or related field (i.e. Chemistry, Biology, or Engineering) preferred.
• High school diploma or equivalent experience required.

• 3 + years GMP hands-on experience in Quality area is required.
• Knowledge of software compliance (21CFR; Part 11) is preferred.

• Proficient with personal digital literacy, specifically Microsoft office applications, with the ability to learn new computer systems quickly.
• Effective interpersonal skills are required, both written and verbal.
• Problem solving skills are required in situations that are not procedurally handled.
• Ability to balance multiple tasks while ensuring timely and accurate completion.
• Ability to work independently.
• Knowledge of the pharmaceutical GMP regulations and their appropriate application to assure compliance with regards to manufacturing problems.
• Knowledge of cGMPs for medical devices or pharmaceuticals.
• Strong attention to detail.
• Excellent interpersonal skills, problem solving skills, planning/organization skills, strategy and customer focus.

• Ability to work in a cold environment with exposure to dry ice, liquid nitrogen cryogenics, hazardous and infectious agents and marked changes in temperature.
• May push/pull 600 lb liquid nitrogen dewars, and work from a platform ladder.
• Use personal protective equipment and implement to safety protocols.
• Must be able to lift and carry up to 50 lbs, and push up to 70 lbs.
• Must be able to process and handle materials frozen on dry ice (-78°C) or liquid nitrogen (-195°C).
• Must be able to work in walk-in freezers or refrigerators periodically for up to 5 hour per day.
• Use a computer up to 6 hours per day.