Quality Lab Specialist

The Quality Lab Specialist will ensure the compliance with requirements of 21CFR Part 211 section 211.22 (a) (c) and consistency of our manufacturing processes through rigorous testing and analysis.

    Essential Functions and Responsibilities:

C Conduct Quality Control Testing:

• Execute a variety of chemical and physical analyses on raw materials, intermediates, and finished products to guarantee compliance with established quality standards.
• Utilize analytical instrumentation, including but not limited to HPLC (High Performance Liquid Chromatography), Gas Chromatography, Karl Fisher, Viscometer, Specific Gravity, and pH to perform quantitative and qualitative analyses.
• Perform method transfer and verification for new testing methods in the laboratory.
• Perform recovery studies and Total Organic Carbon (TOC) testing in support of cleaning validations.

D Data Analysis and Troubleshooting:

• Perform data analysis, identify trends, and troubleshoot issues, taking corrective actions as necessary.

C Compliance and Approval Checks:

• Ensure products meet specifications and conduct final product approval checks.
• Confirm label claims adhere to quality control specifications.

D Documentation, Record-Keeping, and Quality Assessment:

• Develop and gain approval on critical laboratory SOPs, Methods, forms and reports.
• Performs method assessments, with deficiencies and areas for improvement noted within the assessments.
• Author, execute and gain approval on laboratory validation protocols.
• Maintain meticulous and precise records of all testing procedures, results, and any deviations from anticipated outcomes.
• Generate Certificates of Analysis (CoA) for each product batch, providing comprehensive documentation of quality specifications.
• Assess daily quality parameters and quality systems, covering cross-checks, raw materials, calibration, maintenance, procedures, training, auditing, and oversight of analytical testing.
• Document standard operating procedures and identify trends in testing results using data analysis from daily result entries.

T Training and Support:

• Train new quality chemists, and provide technical support to stakeholders, investigating quality problems and implementing actions to follow up.

T Troubleshoot and Investigate:

• Identify and investigate any discrepancies in quality standards, collaborating with production and relevant departments to promptly resolve issues.
• Utilize technical skills to lead or perform in-depth investigations for out of specification results and aberrant data. Draws conclusions and performs root cause analysis investigations and recommends solutions to prevent reoccurrence.

C Continuous Improvement:

• Participate in continuous improvement initiatives by suggesting and implementing enhancements to existing testing methods and processes.
• Establish and maintain a system to ensure proper supplies in the laboratory.
• Ability to train and mentor junior scientists.

C Compliance and Safety:

• Guarantee that all quality control activities adhere to industry regulations and safety standards.
• Contribute to maintaining a safe, clean, and orderly laboratory environment.
• Participate in internal/external audits as needed.

   Other duties:

• Flexibly to work other shifts, and extended hours.
• Perform additional duties as assigned.

     Knowledge & Experience:

• Knowledge of analytical chemistry at a level normally acquired through completion of a bachelor’s degree in chemistry or equivalent. Master’s degree in chemistry is a plus
• 3 years’ work experience in a chemistry analytical laboratory, including proficiency and understating in the following areas:
  • Analytical techniques and instruments.
  • Complex laboratory analysis including but not limited to chromatographic (both HPLC and GC), spectroscopic, and bioassay Analysis, working LC-MS knowledge strongly preferred.
  • TOC Analysis, TLC, ICP-MS Analysis, UV-Vis, and USP Compendial Testing preferred.
  • Stability Program Management.
  • Method qualification, validation, and transfer.
  • Wearing appropriate PPE and following safety guidelines.
• Previous experience with pharmaceutical manufacturing & testing highly preferred; understanding of compliance requirements and regulatory expectations required.
• Demonstrated strong problem-solving skills. Preferred training completion and demonstrated proficiency in Root Cause Analysis methodology.
• Strong oral and written communication skills demonstrated through documentation and presentations.
• Demonstrated strong interpersonal interaction skills.
• Ability to work in cross functional teams as well as across networks.

Exceptional attention to detail and accuracy in documentation.