Senior Qc Analyst Jobs

Senior Analyst

Vacancy Number:

Location: Lamar Twp

Location Address:
88 Heckmans Gap Rd, Mill Hall
Pennsylvania, PA 17751
United States

Closing Date: 9/1/2023

Be part of our journey
As a global leader in specialty chemicals, we continue to succeed and strengthen our delivery of innovative, sustainable and high-performance solutions. We are passionate and excited about how we can develop and utilize new technologies to shape and inspire changes within an ever-growing market place.

Our ideal person
As a business, it’s really important to us that we find the best person for the job and that you have the best opportunity to succeed in the role. To help, we have outlined our expectations for the role and what core skills and experiences we require as well as what would make you an ideal fit. In turn, we hope this helps you evaluate if this is the right job for you.

• To ensure all test methods are in compliance with cGMP and Pharmacopeia requirements
• To assist in the development, validation and implementation of existing and new test methods to ICH standards in support of the site testing requirements
• To ensure all analytical instrumentation is appropriately maintained, calibrated and records maintained in accordance with cGMP
• To develop skills in analytical science and keep up to date with latest technologies in analytical science

• Evaluate test results and determine the course of action for in-process samples and communicate to operations
• Evaluate test results based on expected & historical data & investigate any unexpected results
• To carry out calibration of equipment and maintenance of calibration records
• Perform other sample evaluations and non-routine analyses at the direction of supervision
• To complete appropriate investigation and information in support of out of specification results

• Generate and approve Method Validation documentation
• Maintain proper cGMP documentation on all quality documents including but not limited to inspection plans, analytical data sheets, lab notebooks, log books, forms, OOS reports

• Follow prescribed procedures for sample storage, discarding, and in-process sampling
• Assist in maintaining lab inventory of supplies and reagents
• Follow prescribed procedures for maintaining raw materials, product retains & sample jars
• Clean and maintain lab and lab glassware
• Calibrate or verify instruments and maintain logs
• Maintain lab solutions, reagents & corresponding logs
• Follow prescribed procedures for in-process sampling

• Knowledge of personal protective equipment & its use (e.g., lab coats, safety glasses & shoes, etc.)
• Understand procedures to operate safely in an environmentally sound manner

• Trained in chemical handling and laboratory best practice
• Masters degree preferred in scientific discipline.

• Knowledge of basic chemistry, advanced math including algebra
• Understanding of FDA, ICHQ7 and cGMP
• Experience of ICHQ2 Validation of Analytical Procedures
• Experience with Equipment Verification, IQ, OQ, PQ and validation protocols and reports
• 6 years’ previous lab experience using analytical instruments & lab equipment (GC, HPLC, GCMS, Auto titration, IR, Denver Moisture Solids) & running product tests
• Knowledge of basic laboratory skills and proper techniques for routine operation of analytical instruments

• Must have oral & written proficiency in the English language

• Knowledge of SAP
• Proficient in the use of Laboratory Chromatograph Data systems (CDS)
• Proficient in MS Office

• Attention to detail, planning and organizing, teamwork, stress tolerance, work standards, and ability to work with minimal supervision

• Able to lift a minimum of 35 pounds on a routine basis
• Able to stand, sit or walk for a minimum of 12 hours per day