Job Description

Director of Quality Assurance

QUALIFICATIONS

• Bachelor’s degree in a science/technical field such as Pharmacy, Biology, Chemistry, or Engineering or any bachelor’s degree with three years of experience in pharmaceutical industry in roles covered by GMP oversight.
• Excellent oral and written communications skills.
• Strong ability and motivation to learn.
• Minimum of five years of experience in the pharmaceutical industry and/or FDA experience with at least a minimum of three years of experience in Quality Assurance/Compliance.
• Preferred minimum of seven years of experience in QA/Regulatory Compliance in the p pharmaceutical industry.
• Strong knowledge of global regulatory and cGMP requirements, industry best-practices.
• Strong familiarity with production operations.
• Strong leadership, project management, and technical writing.
• Strong interpersonal, communication, and influencing skills.

WORK ENVIRONMENT

Office environment with business casual dress. May require business attire.'

Benefits:

We’re proud to offer a comprehensive benefits package, including:

• Medical Insurance – PPO & HMO plans
• Dental and Vision Coverage
• Flexible Spending Account (FSA)
• Life Insurance Options
• Short-Term and Long-Term Disability (STD/LTD)
• 401(k) Retirement Plan

2) Quality Engineer

Qualification

Education and/or Experience

• Bachelor’s degree in Engineering, Manufacturing, Mathematics or Business. In lieu of a degree, relevant years of work experience may suffice.
• 0-3 years’ experience working within quality engineering systems.
• Experience working with, or knowledge of, business management systems particularly ISO 13485 preferred, and FDA Title 21 Part 820, QSR.
• ASQ Quality Engineer Certified within one (1) year as requested.
• Experience in or knowledge of SPC and Statistical Analysis.
• Computer skills in MS-Office and Data Analysis Software to calculate statistics (such as Excel, Mini-Tab, etc.).
• Self-Motivated analytical data driven decision maker with strong leadership skills.
• Strong commitment to quality and customer service.
• Demonstrated problem solving skills required
• Leadership Ability

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