The purpose of this position is to provide leadership and oversee the raw material and reference material programs in the Quality Control Department.
· Responsible for daily raw materials laboratory operations including trending, scheduling, staffing, training and troubleshooting to ensure all operations are in full compliance with established Standard Test Methods, compendial methods, vendor methods and safety guidelines.
· Collaborate with QA and Supply Operations to forecast incoming raw materials that require testing.
· Contract lab management to include: direct communication with contract labs, coordination of outsourced testing, collaborating and advising on OOS investigations from contract labs and overseeing/coordinating method transfer to contract labs as needed.
· Manage both the raw material and reference standard programs including driving change controls and document change revisions for updates to specification documents as needed.
· Evaluate and potentially implement program for reduced testing of raw materials.
· Oversee the following QC lab support functions; glassware cleaning, consumables inventory/ordering/stocking, raw data package management/scanning/archiving, chemical inventory, reference standard ordering/qualifying/shipping out for testing.
· Provide effective leadership including setting individual objectives, employee evaluations, providing performance feedback, recognizing employee contributions, coaching and developing staff.
· Provide guidance and risk assessment for the resolution of discrepancies, OOSs, Unexpected results, lab investigations and Corrective and Preventative Actions.
The qualified candidate will possess the following:
· B.S. in science or technical field from an accredited college/university or relevant industry experience.
· Minimum 8+ years of experience in pharmaceutical/Biotech industry or an equivalent combination of education and experience.
· Experience in wet chemistry methods, chromatography methods and particle size testing required.
· Experience with establishing specifications and revising specifications as well as familiarity with keeping up to date on compendial method revisions.
· Experience with managing contract labs.
· Previous leadership or supervisory experience required.
· Working knowledge of cGMP, regulatory compliance (US and other international agencies), and Agilent OpenLab ECM
· Experience providing scientific input, data analysis and written reports for failure investigations.
· Practical knowledge and sound understanding of methods development, validation and regulatory submission.
· Effective oral, written, and interpersonal English communication skills.
· Ability to multi-task with good adaptability to changing business requirements in a dynamic corporate and QC environment.