Quality Control Analysts

Biodextris has an immediate opening for Quality Control Analysts. The QC Analyst executes analytical procedures and ensures compliance with predefined assay acceptance criteria and product specification. The Analyst works under the guidance of the Team Lead / Supervisor to successfully complete analytical activities. She/He interacts with Scientists to support transfer/validation activities, as required. 

Specific Responsibilities:

• Follow company policies and procedures. 
• Perform established laboratory analyses and use the required analytical instrumentation. 
• Execute and document Quality Control (QC) testing in a GMP environment. 
• Participate in activities related to analytical method transfer/optimization/validation. 
• Accountable for the accuracy and completeness of the analytical data she/he generates. 
• Maintain proactive interactions with Management to complete tasks timely and efficiently. 
• Identify OOS, out of trend (OOT) and atypical results and inform Management or delegate immediately. 
• Report quality incidents in accordance with internal procedures. 
• Practice safe work habits and adheres to company safety procedures and guidelines. 
• Analyze and record data in accordance with internal SOPs and Good documentation practices. 
• Maintain Laboratories and workspaces clean and organized. 
• Perform other related assignments and duties as required or assigned by the supervisor (example: IPO forms). 
• Maintenance of accurate documentation of all work in appropriate formats.
• Documentation and electronic data recording in adherence with Biodextris’ Quality Management System (QMS) and relevant regulatory guidelines (e.g. GMP) where appropriate.
• Practice safe work habits and adheres to company safety procedures and guidelines.
  

Skills:

• Some hands-on experience with separation techniques (chromatography HPLC, electrophoresis, etc.) and/or immunological techniques (ELISA, Western Blot) and cell-based assays. 
• Understanding of cGMP, USP, EP and ICH regulations. 
• Ability to perform laboratory work independently and efficiently. 
• Discipline; Detail-oriented; High level of organization. 
• Theoretical knowledge and functional experience in downstream protein and biologics process
  

ACKNOWLEDGEMENT AND AGREEMENT

Education and Experience Requirements:

• B.Sc. degree in chemistry, biology, biochemistry or related field and a minimum of 5 years related experience (or equivalent combined education with relevant work experience).