Quality Control Tech 3

Company Description

Integrated Resources, Inc., is led by a seasoned team with combined decades in the industry. We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively. Since launching in 1996, IRI has attracted, assembled and retained key employees who are experts in their fields. This has helped us expand into new sectors and steadily grow.

Job Description

• Work on complex problems in which analysis of data requires an in-depth evaluation of various factors.
• Exercise judgment within broadly defined procedures and practices to select technique, methods, and evaluation criteria for obtaining results.
• May determine methods and procedures on new assignments and provide guidance for new or less experienced personnel.
• Able to solve problems and make decisions with minimal assistance.
• Able to interpret analytical data (including FT-IR, 1H NMR, MS).
• Write stability protocols, maintain stability chambers/programs, review/manage stability reports, interact with customers to support stability program.
• Develop testing methods to support cleaning verification program; validate or verify methods as necessary.
• Perform cleaning verification by executing existing methods.
• Perform review of analytical data for accuracy and quality.
• Train new or less experienced personnel in SOP content, analytical techniques, and instrument use.
• Meet with internal project groups to keep projects on track.
• Maintain projects and timelines with minimal oversight.
• Execute method transfers into QC and write summary reports.
• Perform method validations and write technical reports.
• Perform instrument calibration (IQ/OQ/PQ/PM) and routine equipment maintenance/repair.
• Analytically test in-process, final products, intermediates, and raw materials. Testing will involve the use of HPLC, GC, KF, DSC, TGA, IR, MS, NMR and XRPD among other tests and instruments.
• Participate in OOS investigations via testing and good documentation.
• Apply critical thinking and good problem-solving skills to thoroughly investigate deviations, identify root causes, and propose appropriate corrective/preventive actions with minimal assistance from supervisor
• Perform requalification of reference standards, and maintain reference standard inventory/documentation.
• Write and revise SOPs including raw material, intermediate, and final product specifications.
• Document testing properly and in a timely fashion, including keeping laboratory notebooks accurate and up to date.
• Demonstrate proper laboratory techniques.
• Work cooperatively within the QC department and with other departments to achieve project goals. Communicate with project management and provide technical updates
• Work in compliance with effective procedures and regulatory requirements outlined in ICH Q7 and 21 CFR Parts 11, 210 and 211 as applicable
• Work in a safe manner and maintain the cleanliness of the work environment.
• Work in accordance with FDA, OSHA, EPA, DNR, DOT, and other regulatory agency guidelines.

Qualifications

Additional Information

With Regards,

Devin Sharma

732-662-4561

Clinical Recruiter

Integrated Resources, Inc.