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![Planet Pharma](https://media.trabajo.org/img/noimg.jpg)
Quality Assurance Specialist
2 months ago
5 days per week onsite - South San Francisco
9 month extendable CONTRACT
$38 - $45 per hr - may have some flex for a strong applicant
Key Responsibilities
- Supports activities for releasing or rejecting raw materials, starting materials, intermediates, drug substance, and drug products.
- Reviews completed batch production and laboratory control records of critical process steps before disposition of drug product for clinical distribution.
- Reviews of Quality Control analysis and results to support product release.
- Performs quality inspection of raw materials, intermediates, packaging and labelling materials.
- Conducts Quality on the Floor activities including, but not limited to, quality walk-throughs, change-over, drug product AQL inspection, and line clearance. Assists on changes that potentially impact intermediate, drug substance, and/or drug product quality.
- Assists in the investigation and resolution of quality events.
- Participates in cross-functional collaborations to meet project timelines and material/product supply requirements
Position Requirements
- Must have 2+ years of related QA experience within the biotech, pharma or medical device industry
- Must have strong GMP Manufacturing experience
- Must have clean room experience
- Must have batch records review, raw material review and inspection.
- Excellent communication skills, both written and verbal
- Strong organization skills and ability to effectively manage multiple priorities.