Manager, QC Lab at Amneal India

Piscataway, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

08 Sep, 26

Salary

140000.0

Posted On

10 Jun, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Testing, HPLC, GC, Spectrophotometric Techniques, Dissolution Testing, Karl Fischer, cGMP, USP/BP/EP/JP Procedures, Laboratory Management, OOS Investigations, Method Validation, SOP Development

Industry

Pharmaceutical Manufacturing

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. Amneal is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, national origin, age, disability, genetic information, protected veteran status, or any other characteristic protected by applicable federal, state, or local laws. If you require a reasonable accommodation to complete the application process or to participate in any part of the hiring process, please contact us at accommodations@amneal.com. Requests will be handled confidentially and in accordance with applicable laws.

Responsibilities

Manage the daily operations of the Quality Control laboratory to ensure timely material delivery and finished product release. Oversee GMP compliance, lead OOS investigations, and manage laboratory personnel and performance.