Quality Assurance Specialist II; Operations

Responsibilities

• Works on problems of diverse scope in which analysis of data requires evaluation of identifiable factors.
• Exercises judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Normally receives no instructions on routine work, general instructions on new assignments.
• Participates in the disposition of batches, including resolution of investigations and deviations to meet lot release time lines.
• Conduct manufacturing and packaging batch record review for accuracy and data integrity (ALCOA+) compliance.
• Performs line clearance and checks for product and packaging activities.
• Author, review and approve Documents in EDMS system to ensure compliance.
• Participate and provide analytical documentation review to support in the release of raw materials.
• Review CofA’s, stability data and release testing documentation in support of final product release.
• Compile Product Quality Reports (i.e. annual product reports, batch review summary report).
• Contribute to quality improvement initiatives.
• Gathers and collates quality metric data.
• Participates in regulatory inspections by assisting in the coordination of readiness activities and inspection logistics.
• Performs data audits and report review as required.
• Supports in quality investigations utilizing QA tools and follows up on corrective actions to closeout.
• Performs other duties as assigned.
• A minimum of a Bachelors degree in a scientific discipline is required.
• Equivalent experience may be accepted.
• A minimum of 3 years related experience is required.
• A minimum of 2 years experience in the pharmaceutical industry working in a GMP environment is required.
• Must have a demonstrated working knowledge of scientific principles. Laboratory instrumentation experience (NMR, HPLC, GC, etc.) a plus.
• Requires strong oral and written communication skills. Knowledge of FDA regulations and cGMPs for drugs are a must.
• Ability to work and coordinate activities with multiple functional groups with sense of urgency.
• Ability to organize, prioritize, plan and schedule.
• Ability to work with minimal supervision.
• Physical Requirements
• Must be able to pass pre-employment drug screening and background check for employment consideration.