Job Description

Manager, QC Lab:

Responsible for managing the activities of the quality control laboratory to ensure timely delivery of materials for use in production and releases of finished products from the laboratory as committed, ensure testing of stability samples within structure of timelines identified in relevant SOP, ensure laboratory activities on par with compliance expectations, and provide top notch inter- and intra-department customer service. Manage the day-to-day operations of the Quality Control laboratory including setting and communicating priorities based on the production schedule. 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. Manage/Enforce laboratory GMP systems and ensure that they are adequate, sustainable and are being followed. Update Laboratory Procedures (SOPs) and Policies. Interpret SOPs/Methods/Specifications and provide clarity as needed. Manage and perform investigation of out-of-specification laboratory results ensuring that all investigations proceed in a logical, orderly and timely manner and that appropriate corrective and preventive actions are identified, when necessary, review and approve investigation reports. Review and signoff process validation/cleaning validation protocols/reports, method verification/validation reports, annual product review reports. Review certificate of analysis to ensure compliance with the specifications. Develop and implement systems to improve laboratory GMP compliance and/or productivity. Make decisions and 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 yearly departmental headcount and turnover of tested samples. Provide input on employee development including promotion and salary increase recommendations. Research and propose capital projects for the laboratory.

Qualifications

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. Must be able to work in a cross-functional team setting, either as a leader or a member, and with complete understanding of team goals. Must understand and apply cGMP requirements applicable to pharmaceutical quality control laboratory. Must have ability to resolve conflicts between employees both within and between departments.

Education Requirements: Must have at least a Bachelor's degree in Pharmacy or Chemistry or Pharmaceutical Manufacturing.

Experience Requirements: Must have 12 months of experience in the position or in a related position

Salary: $137K-$140K per annum. Hours: 40 hrs/wk 8:30am - 5:30pm Location: Piscataway, NJ

Please contact: Karen Mayen @ Ref # 12458