Quality Assurance Manager / Pharmaceuticals

Job description

Overview:
Element has an opportunity for a Quality Assurance Manager. The Quality Assurance Manager is responsible for developing, coordinating, maintaining and supervising the implementation and maintenance of a GMP compliant Quality Management System throughout the laboratory as Management Representative.

Responsibilities:
Manage the Quality Assurance (QA) unit. Responsible for developing, coordinating, implementing and monitoring a quality management system throughout the facility that is compliant with regulatory requirements set forth by the DEA, FDA, and ISO 17025

Perform internal and periodic audits of the laboratory, manufacturing operations, work processes and quality records to ensure compliance with regulatory requirements, standard operating procedures, and polices

Manage the controlled substance (CS) program and ensures compliance with DEA requirements. Assists in procuring, storing, inventorying, and disposal of CS

Manage accreditation applications and renewals including DEA licensing, FDA registration, and ISO 17025. In addition, coordinates and responds to regulatory, client, and 3rd party quality assessments

Skills / Qualifications:
Bachelor's Degree

3-5 years experience in QA (pharmaceutical industry)

GMP analytical, manufacturing preferred

Client/External Audit Host

#LI-GC1

Company Overview:
Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 6,500 brilliant minds operating from 200 sites across 30 countries. Together we share an ambitious purpose to 'Make tomorrow safer than today'.

When failure in use is not an option, we help customers make certain that their products, materials, processes and services are safe, compliant and fit for purpose. From early R&D, through complex regulatory approvals and into production, our global laboratory network of scientists, engineers, and technologists support customers to achieve assurance over product quality, sustainable outcomes, and market access.

While we are proud of our global reach, working at Element feels like being part of a smaller company. We empower you to take charge of your career, and reward excellence and integrity with growth and development.

Industries across the world depend on our care, attention to detail and the absolute accuracy of our work. The role we have to play in creating a safer world is much bigger than our organization.

Diversity Statement:
At Element, we always take pride in putting our people first. We are an equal opportunity employer that recognizes diversity and inclusion as fundamental to our Vision of becoming "the world's most trusted testing partner".

All suitably qualified candidates will receive consideration for employment on the basis of objective work related criteria and without regard for the following: race, color, age, religion, gender, national origin, disability, and/or protected veteran status, or other characteristics in accordance with the applicable governing laws.

TIC Council Statement:
Element is proud to be a full member of the Testing, Inspection & Certification Council (the "TIC Council"), an international association representing independent testing, inspection and certification companies.

Members of the TIC Council must implement and abide by the TIC Council Compliance Code. Element has therefore issued an overarching Code of Conduct which is supported by our Compliance Programme. A copy of the Code of Conduct and more information about our Compliance Programme can be found in the section of .