Quality Manager
Quality Manager
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$ 120 - 150
1 Vacancy
Job Description
Overview
Element is currently hiring for a Quality Manager to join our growing team in Santa Fe Springs CA. The Quality Manager provides direct oversight of Quality personnel at the Santa Fe Springs location. This position ensures the site Quality Management System is compliant to applicable regulations as well as Element Business Unit policies and procedures.
The pay range for this role is set between $120k$150k but will largely depend on the level of direct relevant experience.
Responsibilities
- Develop and ensure compliance with applicable regulatory requirements
- Establish and maintain strong relationships with clients and accreditation bodies.
- Remain knowledgeable on the quality and regulatory landscape and communicate to the rest of the site
- Provide leadership and representation of Element to third party organizations clients accreditation bodies/committees suppliers/vendors
- Create postaudit/inspection responses and ensure all components are completed in a timely manner
- Interacting with clients and regulatory authorities
- Support the Quality and regulatory training and development of colleagues (including cGMP training including FDA and ICH guidelines)
- Participate and advise on adjustments to quality procedures and processes as necessary
- Maintain high level of ethics in day to day operations and decisions.
- Provide guidance and expert advice on technical systems quality risk management or processrelated business improvement aspects
- Maintaining a satisfactory Quality System
- Supervising Quality and Metrology Personnel
- Managing the development review and approval of Standard Operating Procedures and all other cGMP documentation
- Ensure proper Review and approval of validation qualification protocols and reports
- Ensuring that qualityrelated investigations are properly conducted and resolved
- Ensuring that internal audit requirements are met
- Approval of Suppliers/Vendors
- Maintaining Controlled Substance Program
- Help create and maintain a positive work environment
- Other duties as assigned.
Skills / Qualifications
- BS in Lifesciences (ie. Biochemistry Biology Molecular Biology)
- 8 years Quality experience in cGMP
- Broad knowledge of GMP and GLP regulations
- Knowledge of ISO 17025 preferred
- Knowledge of CFR parts 11 210 and 211
- Knowledge of compendial references (USP EP JP etc)
- Success in writing project plans and driving them to conclusion
- Proficiency in standard office software and computer systems
- Strong interpersonal and communication skills
- Excellent organizational skills ability to manage multiple projects under changing priorities
- Teamoriented leader and coach
- Strong public speaking skills with the ability to deliver complex messages to all audiences adopting messaging to fit the education level of the audience.
- Proficiency in Microsoft Applications (Word Excel PowerPoint Outlook)
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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 601.35(c)
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Required Experience:
Manager
Employment Type
Unclear
