Quality Assurance Specialist I

About this opportunity :

As a Quality Assurance Specialist you will be responsible for documenting and auditing cGMP practices for the site.   The position develops and revises QA procedures to strengthen cGMP compliance as per the USFDA Title 21 Code of Federal Regulation Part 210, 211 and Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients. 

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. 

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