TEMP Sr. Quality Specialist l, Manufacturing Quality

Responsibilities

• Perform activities related to batch record process flow (i.e. Issuance, Review, Closure).
• Perform incoming receipt of patient material and packing of Final Product.
• Perform Final Product disposition and release.
• Perform Raw Material review and approval.
• Review and approve GMP facility work orders.
• Review and approve system, equipment or method validation protocols, reports, and related validation documents (ie. Requalification, URS, FRS, RBRAs etc).
• Conduct product complaint investigations.
• Processes deviations and non-conformances.
• Track/trend metrics and reports data to Senior Management for escalation as necessary.
• Processes change controls (authors/review change impact and risk assessments).
• Provide support for any other duties assigned.
• Represents department in cross-functional teams, projects and GXP-related problem resolution.
• Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.

Qualifications

• Education and Professional Experience: Bachelor’s degree in a scientific discipline or equivalent. 7+ years in a cGMP regulated environment with related experience within the biopharmaceutical or biotechnology industry preferred. 10+ years of relevant work experience can be substituted for a 4-year course of study leading to a Bachelor’s degree.
• Knowledge of current regulatory requirements in support of cGMP manufacturing operations (i.e., FDA and ICH guidelines).
• Experience in knowledge of sterile products aseptic manufacturing processes and testing preferred.
• Understanding of facility/building related knowledge (ISO classifications, air handling units, differential pressures).
• Proficient in MS Office applications.
• Ability to gown aseptically for work in Clean Room environments.