Sr. Quality Assurance Specialist
Performs a wide variety of activities to ensure compliance with applicable GXP requirements. Assures all operations are performed in compliance with company procedures and Quality Standards. Monitors designated phases of the manufacturing operations. Writes, revises, reviews, and approves standard operation procedures and related manufacturing documents. May conduct investigations related to manufactured products. Applies knowledge of good manufacturing practices on a daily basis.
Essential Duties and Responsibilities
Works on extremely complex problems in which analysis of situations or data requires an evaluation of intangible variables. Acts independently to determine methods and procedures on new assignments. Exercises independent judgment in developing methods, techniques and evaluation criteria for obtaining results. Uses professional concepts to achieve objectives in creative and effective ways. Performs batch record review, including resolution of investigations and deviations to meet time lines. Performs lot disposition. Interfaces with pharmaceutical partners on quality and product issues, and FDA during cGMP audits. Performs review of technical reports on process development. Participates in design control activities including review and approval of design inputs, outputs, changes, verification and validation reports. Participates in internal and external audits in accordance with current regulatory compliance. Participates in Quality investigations utilizing QA tools and follows up on corrective actions to closeout. Participates in Quality Oversight of Contract manufacturing. Performs data audits and report reviews as required. Identifies procedural and systematic compliance risk and recommends practical corrective actions that complement functional area business processes. Reviews regulatory filings. Approves specific procedures, master batch records, specifications and critical process parameters, discrepancy investigations and batch release as designated by higher level. May provide supervision to junior staff.
A minimum of a Bachelors degree in a scientific discipline is required. Equivalent experience may be accepted. A minimum of 8 years related experience is required. A minimum of 6 years experience in the pharmaceutical industry working in a GMP environment is required. A demonstrated working knowledge of scientific principles is a must. Strong oral and written communication skills are required. An in-depth knowledge of FDA regulations and cGMPs for drugs and device are a must. Previous supervisory experience is preferred.