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Company

Element Materials Technology

Address , Concord, 94520, Ca
Employment type
Salary
Expires 2023-10-01
Posted at 9 months ago
Job Description
Overview:
Element has a current opportunity for a Quality Control (QC) Reviewer to join our gorwing team in Concord, CA. The (QC) Reviewer main duties are to perform peer review of GMP Microbiological data/ test records against client and regulatory requirements as applicable such as ISO 17025, USP, EU, GMP and FDA and guidelines.
Responsibilities:
  • Write protocols and revise standard operating procedures as needed
  • Perform investigations to resolve issues related to assay failures, system deficiencies and OOS/OOT results
  • Review of raw data and test records from QC testing performed
  • Learn testing techniques performed in the laboratory to understand raw data
  • Additional duties as needed
  • Review COA’s (certificate of analysis) against raw data
  • Perform data review of QC testing records to ensure data integrity and adherence to standard operating procedures and cGMP principles
Skills / Qualifications:
  • Excellent organizational skills, good written and verbal communication skills in English, strong computer skills and customer service. Ability to work as a team member
  • Authorization to work in the United States
  • Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
  • A B.S. in science is desired or 2-5 years of pharmaceutical/biotechnology industry experience in a GMP environment. Experience in a GMP microbiology lab, LIMS, GMP investigations is highly desirable
#LI-TK1
Company Overview:
Element is one of the fastest growing testing, inspection and certification businesses in the world. Globally we have more than 7,500 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: age, disability, ethnic origin, gender, marital status, race, religion, responsibility of dependents, sexual orientation, or gender identity or other characteristics in accordance with the applicable governing laws or other characteristics in accordance with the applicable governing laws.