Director of Quality

Open Scientific provides contract staffing and direct hire recruitment services for the scientific, engineering, laboratory and manufacturing sectors.

A large pharmaceutical company is looking for a Director of Quality in Suffolk County. This role is responsible to direct and oversee chemical, physical, and microbiological testing and auditing of raw materials, in-process, finished products, and stability samples in QC laboratories in compliance with all SOPs, test procedures, and cGMP. This role will also ensure quality control laboratory delivers materials for use in production and releases of finished products from the laboratory as committed, and testing of stability samples within strictures of timelines identified in relevant SOP, laboratory activities on par with compliance expectations, and provide top notch inter- and intra-department customer service.

Pay Rate: $120k to $150k

Essential Functions

• Direct laboratory related investigations to ensure all investigations proceed in a logical, orderly, and timely manner.
• Where required to strengthen laboratory investigations, prepare appropriate protocols and ensure execution of such protocols in a timely manner and in compliance with appropriate SOPs.
• Liaise with AR & D group for transfer of in-house developed and validated methods for finished products and APIs.
• Maintain knowledge of the potential impact of Quality Control activities on activities in other departments and effectively communicate this information to the appropriate personnel in a timely manner.
• Provide input to laboratory employees to interpret SOPs and test methods where instructions may not be clear.
• Review COAs to ensure compliance with all specifications and approve for laboratory release.
• Implement solutions where deficiencies are found. Provide formal and informal performance feedback to direct and indirect reports including disciplinary action when necessary.
• Provide input on monthly departmental headcount and turnover of tested samples.
• Develop and implement systems to improve laboratory GMP compliance and/or productivity.
• Review and signoff process validation/cleaning validation protocols/reports, method verification/validation reports, annual product review reports, and method transfer reports.

QUALIFICATIONS

• Master Degree (MS/MA)Chemistry or related technical field Required
• In lieu of the preferred requirement(s), equivalent relevant experience will be considered:

Specialized Knowledge

• Must possess skills in analytical testing involving spectrophotometric analytical techniques, chromatographic techniques (HPLC/GC) employing different data acquisition software, dissolution, dissolution profile and drug release, disintegration, and moisture determination (Karl Fischer, Coulometric, LOD).
• Must be able to understand and explain compendial (USP/BP/EP/JP) procedures.
• Must be able to identify problems during the course of analysis and participate in troubleshooting of instrument-related and procedure-related problems.
• The incumbent must be able to effectively plan and organize multiple tasks with a high degree of complexity in order to complete them in a timely fashion to meet customer needs.

All your information will be kept confidential according to EEO guidelines.