Senior Quality Engineer

VERO BIOTECH INC•Atlanta, GA

1d•Onsite

About The Position

Responsible for product quality through proper design and implementation of appropriate procedures and specifications, as well as finished goods quality.

Requirements

Bachelor’s Degree in technical field and minimum 2 years related experience for Quality Engineer or 4 years for Sr. Quality Engineer
Strong knowledge of pharmaceutical manufacturing processes, computer and equipment validation, GMPs, and product/process validation.
Knowledge of quality engineering principles.
Ability to analyze component and final product processes to improve overall efficiency and quality.
Thorough knowledge of GMP, CFR, and factors impacting compliance.
Knowledge of and ability to utilize statistic in evaluation of data.
Thorough knowledge of FDA regulations
Experience with laboratory environment, equipment, and safety procedures.
Commitment to excellence and high standards
Excellent verbal and written communications skills in English
Ability to manage priorities and workflow
Versatility, flexibility, and a willingness to work within constantly changing priorities with enthusiasm
Acute attention to detail
Demonstrated ability to plan and organize projects
Ability to work independently and as member of various teams and committees
Proven ability to handle multiple projects and meet deadlines
Ability to develop clear, concise, and timely oral and written reports.

Nice To Haves

Master’s Degree Preferred
ASQ Certification preferred.

Responsibilities

Authors, executes and reports on qualification/validations in the following areas: Equipment Qualifications, Facility Qualifications, Software Validation, Computer System Validation, Test Method Validations, Stability Program Studies, Human Factors
Supports new product development teams to assure product quality is achieved through proper design, testing, and Engineering and Quality specifications
Assists in risk management program, assesses FMEA updates and controls
Reviews/develops engineering test/qualification protocols, where required, to assure product/design changes are properly validated prior to release
Supports process validation activities.
Communicates and carries Quality Engineering philosophy to other internal groups
Assures compliance to documentation procedures
Reviews change requests
Performs process capability analysis and assists in design of experiment activities
Interfaces with Product and R&D Engineering groups on design and specification-related issues as well as for approvals, as required.
Works closely with Quality System personnel to assure compliance with quality system requirements.
Performs other duties and responsibilities, as required