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. Creates and/or revises departmental procedures and work instructions.  Creates/updates department metrics.  Uses professional concepts to achieve objectives in creative and effective ways. Performs batch record review, including resolution of investigations and deviations to meet timelines. 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/Leads in internal and external audits in accordance with current regulatory compliance. Participates/Leads in Quality investigations and change controls utilizing QA tools and follows up on corrective, preventive and change 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. Serve as the subject matter expert (SME) and/or assist in multiple quality systems that may include but not limited to quality agreements, supplier qualification and monitoring, external/internal audits system and activities, controlled drug substances (CDS), product complaints, and product retain management May provide supervision to junior staff.

Requirements

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.