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Quality Assurance Associate
3 months ago
**Position**:Quality Assurance Associate
**Department**:Quality Assurance
**FLSA Status**:Non-Exempt
**Location**:Carlsbad, CA (On-site)
**Position Description**: The Quality Assurance Associate will play a vital part in maintaining and enhancing our Quality Systems. Reporting directly to the Senior Manager QA, you'll actively participate in various Quality Systems, lead investigations, support controlled document systems, and ensure regulatory compliance.
**Primary R**esponsibilities**:
- Actively contribute to all Quality Systems such as Deviations, Non-conformances Change Control, CAPA, Risk Assessments, Internal Audits
- Lead or assist in investigation activities, perform root-cause analysis, and identify effective corrective actions and process improvements
- Support the controlled document systems, including authoring and revising QAU SOPs
- Oversee the RODAC Testing by QC Personnel and ensure results are reviewed and properly archived
- Participate in Regulatory Inspections and Client Audits, as needed
- Cross train to provide secondary support for performance of GLP study audits
- Identify and lead continuous improvement initiatives
- Review and update QA SOPs as needed per internal procedure for controlled documents
- Assist in maintaining the facility in an inspection ready state
- Serve as QAU representative on cross functional project teams
- Communicate effectively with co-workers, management and clients
- Additional duties, as required
- A Bachelor's degree in Science, preferably in biology or similar field
- Two years of Quality Assurance experience within the pharmaceutical or biotechnology industry, in a regulated environment; GLP or other regulatory experience is desired
- ISO 9001:2015 Quality Systems experience, a plus
- An ability to organize, understand, and present complex information at a level that is appropriate for technical and non-technical backgrounds
- Attention to detail and analytical thinking proficiency
- Excellent communication skills, interpersonal skills and organizational skills
- Strong technical writing skills
**Benefits**:
Pharmaron cares about our work community and offers a variety of benefits allowing employees the opportunity to customize a benefits package that meets their personal needs. Company benefits include the following:
- Medical, Dental & Vision Insurance Plan with Employer Contribution
- Health Reimbursement Account Funded by Employer
- Healthcare & Dependent Care Flexible Spending Accounts
- Employee Life and AD&D Insurance 100% Employer Paid
- Voluntary Life and AD&D Insurance for Employee, Spouse & Child(ren)
- Short and Long Term Disability 100% Employer Paid
- 401k with Employer Match
- Employee Assistance Program
**About Pharmaron**
Pharmaron (Stock Code: 300759.SZ/3759.HK) is a premier R&D service provider for the life sciences industry. Founded in 2004, Pharmaron has invested in its people and facilities, and established a broad spectrum of research, development and manufacturing service capabilities throughout the entire drug discovery, preclinical and clinical development process across multiple therapeutic modalities, including small molecules, biologics and CGT products. With over 19,000 employees, and operations in China, the U.S., and the U.K., Pharmaron has an excellent track record in the delivery of R&D solutions to its partners in North America, Europe, Japan and China.
Pharmaron is proud to be an Equal Employment Opportunity and Affirmative Action employer.
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