Manager, Quality Assurance

Eurofins•San Diego, CA

5h•$80,000 - $100,000

About The Position

This position is Responsible for leading Quality Assurance Department in accordance with vision, values, and strategic goals of the company. It will involve overseeing and facilitating efficient quality operations, assuring consistent client service, implementing laboratory practices as applicable to current regulatory standards, working with client and agency audits and correspondence, maintaining certifications, Quality Assurance policy development, and maintenance, following up promptly on any quality and compliance related issues, and implementing respective CAPA actions to assure adherence to the required quality metrics. Other responsibilities are as follows: Chairs Quality Management Oversight Meetings to monitor for trends, identify improvements, and assure the effectiveness of the Quality Management System Implements, prepares, and presents training programs as required to satisfy regulatory requirements Manages Quality Management System Applies industry experience to establish and implement best laboratory practices and quality system standards as related to compliance Performs QA review and approvals as required Maintains current records for required certifications and/or accreditations Communicates with client and agency auditors, responds to findings, and effectively addresses concerns or findings Provides information for monthly/quarterly reports to senior site management Identifies, implements, and assures adherence to effective quality control measures Mentors QA staff and provides leadership through demonstration of the vision, values, and strategic goals of the company Leads complex projects through to completion Communicates effectively with client staff members Performs other duties as assigned

Requirements

Bachelor’s or Master’s degree in Chemistry or closely related science field from a four year college/university or equivalent education and job experience
At least five years of bio/pharmaceutical chemistry/microbiology/biopharmaceutical experience with some data review responsibilities and a working knowledge of regulatory requirements
Solid understanding of chemistry/lab practices.
Knowledge of auditing techniques
Familiarity with at least one scientific technique (HPLC, GC, etc.)
Self-confidence, leadership, ability to reason, make sound decisions, and delegate
Empathy and sensitivity towards others
Motivation to excel and inspire excellence in others
Ability to manage the work of others and see projects through to completion
Strong communication including verbal, writing, and presentation skills
Ability to communicate effectively and relate well to people
Mental and emotional stability and maturity
Ability to handle personal stress and diffuse stress in others
Strong organizational skills and ability to handle multiple priorities
Sets positive example for others
Dedication to quality, ethics, and customer service
Pride in appearance, conduct, and company
Ability to work effectively under pressure to meet deadlines
Good negotiation and reasoning skills
Excellent written and verbal communications skills
Good judgment and tact recognizing and solving problems
Recognized as understanding, interpreting, and following company policy

Responsibilities

Chairs Quality Management Oversight Meetings to monitor for trends, identify improvements, and assure the effectiveness of the Quality Management System
Implements, prepares, and presents training programs as required to satisfy regulatory requirements
Manages Quality Management System
Applies industry experience to establish and implement best laboratory practices and quality system standards as related to compliance
Performs QA review and approvals as required
Maintains current records for required certifications and/or accreditations
Communicates with client and agency auditors, responds to findings, and effectively addresses concerns or findings
Provides information for monthly/quarterly reports to senior site management
Identifies, implements, and assures adherence to effective quality control measures
Mentors QA staff and provides leadership through demonstration of the vision, values, and strategic goals of the company
Leads complex projects through to completion
Communicates effectively with client staff members
Performs other duties as assigned