QA Specialist - Microbiology
IconmaOceanside, CA
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Job Description
Our Client, a Biotech company, is looking for a QA Specialist for their Oceanside, CA location.Responsibilities:
- Perform Quality Assurance related production and production related activities (Batch Record review, Line Clearance, and on the floor support)
- Provide Quality oversight/approval of Quality Control activities (Method transfer, Certificate of Analysis, and Stability)
- Approve shipments and provide oversight during packaging of product
- Ensure timely assessment and closure of discrepancies, Deviations, CAPAs and Change Controls
- Ensure timely assessment and closure of Laboratory Investigations
- Ensure timely assessment and closure of batch and material hold events
- Communicate lot disposition pending issues to Management
- Provide on-the-floor QA oversight and support to ensure compliance to GMP throughout the areas
- Perform walk-throughs and process observations
- Perform Document Control administrative activities including archival and updating of site training records
- Support Regulatory Body Inspections of the facility
- Ensure products are manufactured in compliance with regulatory and GMP guidelines.
- Escalate issues that may adversely impact timely release of product
- Identify compliance risks and escalate the issues to appropriate levels of management for resolution
- Generate and update procedures and forms as needed
- 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. Experience with Veeva, Smartsheet and LIMS is highly desirable
- 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
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
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FAQs About QA Specialist - Microbiology Jobs at Iconma
What is the work location for this position at Iconma?
This job at Iconma is located in Oceanside, CA, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Iconma?
Employer has not shared pay details for this role.
What employment applies to this position at Iconma?
The employer has not provided this information. This may be discussed during the hiring process.
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