Quality control manager

A Few Words About Us - Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

Our Client is looking for Quality Control Manager-with Small molecules, validation, analytical chemistry, methods validations etc. experience…..!!!!!

Summary: Manage Small Molecules/Oral Solid Dosage analytical test methods validations and transfers for release and stability testing of commercial pharmaceutical products. 

Manage complex scientific knowledge of analytical methods and updates . Manage a staff of qualified scientific employees and provide guidance in the area of expertise.

RESPONSIBILITIES: 

• Method design (re-design) and validation (re-validation) 

• Method performance monitoring (trending), control and troubleshooting 

• Methods transfer working with internal and contract sites 

• Author analytical regulatory sections and response to questions 

• Work with interconnected departments and other groups in Pharmaceutical Operations 

• Analytical expert for assay optimization, validation and transfer 

• Present analytical issues and findings to senior management

QUALIFICATIONS AND SKILLS NEEDED: 

• A bachelor’s degree in analytical chemistry with 5+ years or a Master’s with 3+ years of leadership and experience in a pharmaceutical/biotechnology industry.

• Experience directing activities related to analytical method development, qualification and validation of Small Molecules, Oral Solid Dosage assays, method performance monitoring, methods transfer and working with external laboratories. 

• Experience with regulatory writing of analytical sections and response to questions 

• Excellent communicator, author and creative thinker with extensive knowledge in the area of expertise 

• Specific techniques include chromatography, particle size, XRPD, Dissolution and Disintegration, ICP-MS, KF and compendia methods 

• Excellent project and people manager who can motivate, direct projects, and align scientific

Regards

Pooja Mishra

Clinical Recruiter

Integrated Resources, Inc. 

IT Life Sciences Allied Healthcare CRO

Certified MBE |GSA - Schedule 66 I GSA - Schedule 621I

Tel: 732 429 1636

(W) 732-549-2030 x 214 | (F) 732-549-5549

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