Quality Control Analyst

Job Title: Quality Control Analyst

Duration: 6+ Months

Location: Rensselaer, NY 12144

Qualifications:

• Bachelor’s with major in Chemistry or related scientific discipline with a minimum of 6 years of experience in a QC laboratory environment OR equivalent combination of relevant education and experience may be substituted as appropriate
• Investigations experience including root cause analysis, writing, and CAPA identification

Monday - Friday 8am-5pm

Responsibilities:

• Work with QC and cross functional team as needed to meet required QC investigation deadlines in a proficient manner, while driving to root cause, and identifying the appropriate & effective corrective and preventive action.
• Ensure QC investigations are initiated in a timely manner, initial impact completed and submitted for QA reviews within stipulated timeframes
• Conduct and document investigations as needed, while also working with customers as required.
• Conduct, and document OOS investigations, including coordination with customers as required by quality agreements and regulatory commitments.
• Apply 6M, 5 Why or fishbone analysis to drive root cause
• All investigations will follow procedures in accordance with cGMP’s.
• Work with the team to document and drive critical investigations to closure.
• Maintain metrics for the laboratories to identify CAPA opportunities including, analyst error rate, equipment failure rate, and test method issues.
• Ensure all investigations are executed in full compliance with cGMPs, Curia SOPs, and global quality standards.
• Work with the team to develop investigation strategies to meet customer commitments and requirements.
• Provide investigation updates to cross functional areas and management, as required.
• Develop an expertise in documenting investigations and create templates to use for ease of reference and consistency.
• Identify CAPA’s and update training modules to reduce analyst error rate
• Work independently and with the QC team as the primary investigator on all critical laboratory related investigations.