Are you well-versed in quality control and analytical methods within API production? Looking to find an entrepreneurial role within a well-established and respected biotech/pharma company? This could be the perfect next step in your career!
What You'll Do:
The Senior Quality Control Analytical Scientist, Pharma will play a cornerstone role in the development, characterization, validation, and implementation of analytical methods for the manufacture of Active Pharmaceutical Agents (API) in a brand new CMC facility. Some of the key responsibilities include:
Independently perform and oversee all aspects of analytical method development, method validation and method implementation.
Write, review and revise, as necessary, inspection plans, test methods, SOPs and other QC department procedures, for accurate and complete content, and ensuring they meet documentation policy.
Evaluate and interpret analytical testing results. Act as primary reviewer of analytical data generated from raw materials test, in process testing, and final product testing.
Collaborate with Manufacturing and R&D to develop analytical methods for API manufacturing.
Perform laboratory investigations for Out of Specification results or other testing abnormality. Investigate complaints from customers and internal deviations/nonconformances as assigned.
Report results of release testing according to company Quality System requirements. This includes the input of results into SAP Quality Module and issuing COA’s as needed.
Prepare and/or maintain QC testing materials, retention samples, and reference standards.
Maintain a working knowledge of QC Lab instrumentation and associated analytical methods utilized for product release testing.
Perform analytical method evaluation and/or re-validation upon request, as part of installation, operation, performance qualification efforts related to new or changed laboratory instrumentation.
Support internal and external customers to ensure that proper and timely execution of all aspects of the clinical analytical method life cycle.
Provide training on QC methods and instrumentation in the laboratory, as needed.
Demonstrate inclusion through their own words and actions and is accountable for a safe workspace. Acts with kindness, curiosity and respect for others.
Understand and comply with ethical, legal and regulatory requirements applicable to our business.
What You'll Bring:
Master’s or Ph.D. degree in Analytical Chemistry, M.S. with approximately 10+ years, or Ph.D. with approximately 8+ years in a Quality Control lab performing method development, validation and implementation related to API testing.
Extensive knowledge on the use and troubleshooting of typical analytical instruments, including HPLC, NMR, GC, ICP-MS, MS/QToF, Karl Fisher, and XRPD.
Experience in all aspects of analytical method development, method validation and method implementation related to API testing. This includes experience with the use of statistical tools to analyze data.
Experience writing and reviewing Inspection Plans, test methods, SOPs and other QC Dept procedures, for accuracy and complete content, and ensuring they meet documentation policy.
Strong knowledge of current regulatory guidelines and cGMP requirements.
PREFERRED BUT NOT REQUIRED QUALIFICATIONS:
Ph.D. with 2+ years or M.S. with 8+ years’ analytical method development experience in a pharmaceutical company.
Experience in preparing regulatory submissions and responding to regulatory inquiries.
Take the next big step in your career and Apply Now!
Questions? Contact Andie Veach directly at Andie@CarexScientific.com
Carex Consulting Group is an equal opportunity employer. We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, marital status, disability, gender identity or Veteran status.