Quality Assurance Specialist I

Key Responsibilities

• Acts as departmental resource for cGMP manufacturing programs.
• Work collaboratively with all departments to ensure manufacturing programs are delivered on time.
• Make and act upon GMP decisions.
• Writes, reviews and/or approves SOPs and other compliance documents for cGMP programs.
• Reviews and authorizes batch production records and quality control documentation.
• Sets-up and tracks material flow and material-labeling process to ensure compliance with cGMP program.
• Collaborate and interact internally to support the highest quality customer service.
• Acts a liaison between Avecia and client with respect to compliance in cGMP manufacturing programs.

Required Skills/Abilities

• BS/BA in science with 1-3 years Quality Assurance cGMP experience or an Associate degree with 5+ years of Quality Assurance cGMP experience in the area of Active Pharmaceutical Ingredients (API) manufacturing or related industrial experience.
• High level of knowledge in cGMP guidelines as specified in ICH Q7A.
• Experienced at writing and reviewing GMP documents.
• Solves complex, non-routine analytical problems.
• Very strong oral and written communication skills.

Pay

The annualized salary range for this position is between $58,100.00 - $71,100.00.