Quality Specialist I
Quality Specialist I
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Job Description
Overview
Element has a current opening for a Quality Specialist I to join our growing team in Santa Fe Springs CA. The Quality Specialist I supports the Quality Assurance function by performing routine QA activities to ensure compliance with applicable regulatory requirements (e.g. FDA 21 CFR Part 11 210/211 ISO 17025) and internal quality standards. This entry-level position assists with reviewing analytical data packages monitoring compliance in laboratory activities equipment and method qualifications review and approval and document control. Reports to the Quality Supervisor and/or Quality Manager.
$25hr-$35hr DOE
Responsibilities
- Perform QA review of analytical data packages logbooks notebooks and laboratory reports for completeness accuracy and compliance with client requirements and regulatory expectations.
- Support timely issuance revision and control of SOPs test methods protocols and logbooks through the document control system.
- Assist in the documentation and tracking of deviations events and non-conformances.
- Support QA Audit Walk-throughs to observe laboratory practices and verify compliance with Good Documentation Practices (GDP) and cGMP.
- Participate in QA review of equipment qualification and method validation documentation prepared by technical staff.
- Ensure that controlled records are archived and retained according to company procedures and regulatory expectations.
- Collaborate with Laboratory Operations Client Services and other departments to support client audits regulatory inspections and internal continuous improvement efforts.
Skills / Qualifications
- Bachelors degree in Chemistry Biology Pharmaceutical Sciences or related field.
- 02 years of quality assurance or laboratory experience in a GMP-regulated environment (internships or academic lab work may be considered).
- Familiarity with FDA and ICH guidelines applicable to pharmaceutical testing particularly 21 CFR Parts 210 211 and 11.
- High attention to detail and commitment to data integrity and accuracy.
- Strong written and verbal communication skills.
- Ability to prioritize tasks and meet deadlines in a fast-paced client-driven environment.
- Ability to collaborate with colleagues and work effectively as part of a team
- Experience in a pharmaceutical or analytical contract laboratory setting.
- Familiarity with electronic quality systems (e.g. MasterControl Veeva TrackWise) and LIMS.
- Working knowledge of method validation equipment qualification or raw data traceability principles.
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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 worlds 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.
The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about discussed or disclosed their own pay or the pay of another employee or applicant. However employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information unless the disclosure is (a) in response to a formal complaint or charge (b) in furtherance of an investigation proceeding hearing or action including an investigation conducted by the employer or (c) consistent with the contractors legal duty to furnish information. 41 CFR 60-1.35(c)
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Required Experience:
Unclear Seniority
Employment Type
Unclear
