What are the responsibilities and job description for the QA Specialist position at Actalent?
Hiring a QA Specialist for a great scientific company in Davis, CA! Great team environment and culture!!
Onsite, M-F Day shift
Summary
The Quality Assurance Specialist is responsible for the implementation and oversight of the company to improve operational efficiencies.
Essential Duties & Responsibilities
1. Implement and oversee the company’s Quality Documentation System Program
2. Conduct internal audits, personnel training, and provide direct feedback of Quality status to all levels of staff and management
3. Identify process and operational improvements
4. Identify critical control points and implement necessary quality procedures
5. Create, implement, and maintain departmental SOPs and forms
6. Review records and documents to ensure compliance with internal procedures, GMP, and other regulatory requirements
7. Conduct trending analysis
8. Provide support during inspections and audits
9. Manage the NCR and corrective actions processes
10. Document control management
11. Serve as a liaison for national and international regulatory authorities
12. Perform additional duties as assigned by supervisory or management personnel
Qualifications
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Education/Experience
• Must have a Bachelor’s degree in the sciences or related field
• At least 2 years previous work experience in a similar quality documentation position required
Computer Skills
• Proficient in Microsoft Word, Excel, and Outlook
• Knowledge of Microsoft Access preferred
• Internet Explorer, Chrome, or Firefox
• Must be willing and able to learn other software programs as needed
Knowledge, Skills and Other Abilities
1. Excellent attention to detail
2. Knowledge of basic lab equipment and analytical instrumentation required
3. Strong technical writing skills
4. Diverse communication skills
5. Leadership experience
6. Internal audit experience
7. Regulatory environment experience
8. Knowledge of FDA Quality System Regulations (cGMP) and International Standards (ISO) pertaining to medical devices, 21 CFR Part 820, ISO 13485, ISO 14971.
9. Must be able and willing to adhere to corporation personnel policies and practices, including attendance and punctuality requirements
About Actalent:
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
