Senior QC Analyst

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 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 test methods are in compliance with cGMP and Pharmacopeia 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
• 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
• To carry out calibration of equipment and maintenance of calibration records

• 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
• Generate and approve Method Validation documentation

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

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

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

• 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 chemistry, advanced math including algebra
• Knowledge of basic laboratory skills and proper techniques for routine operation of analytical instruments
• 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

• Must have oral & written proficiency in the English language

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

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

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