Highlights
To provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and/or novelty. Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.
Numbers & Facts
| Location | El Segundo, CA |
| Industry | Management Consulting Services |
| Salary | $39.24–$44.24 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | https://www.iconma.com/ |
Description
Our client, a Biopharmaceutical company, is looking for a QA Specialist – II for their El Segundo, CA location.
Responsibilities:
- To provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and/or novelty. Ensure records are properly initiated, investigated and resolved in accordance with established timelines.
- To provide QA oversight and approval of CAPA and EV records that have moderate to significant levels of complexity and/or novelty. Ensure CAPAs are initiated and resolved in a timely manner.
- Ensure escalation of deviations per procedures
- Identify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant manner
- Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.
- Additional duties as assigned.
- These duties can be delegated to designated deputies of a satisfactory qualification level as needed.
Requirements:
- Master’s Degree and OR
- Bachelor’s Degree and 2+ years’ experience in the biological sciences or related field OR
- AA Degree and 4+ years’ experience in the biological sciences or related field OR
- High School Degree and 5+ years’ experience in the biological sciences or related field
- Quality Control background in Analytical, Virological, and Microbiological testing
- Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards
- Ability to effectively negotiate and build collaboration amongst individuals
- Proficient in MS Word, Excel, Power Point and other applications.
- Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment
- Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Benefits
401K, Employee Referral Program, Life Insurance
About Company
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
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