Senior QA Associate, San Diego, CA
The Senior Quality Assurance (QA) Associate will have responsibility for performing a variety of tasks related to Quality Assurance systems and compliance programs supporting GMP site activities. The position requires experience working in GMP regulated environments and practical knowledge in FDA and international regulatory requirements as applicable to development and investigational phase products.
Essential Duties and Responsibilities:
- Assists in reviewing, processing, and maintaining company's Document Control system through:
- Organization and maintenance of controlled documents.
- Writing, reviewing/revising, approving, and processing Standard Operating Procedure (SOP), Batch Record, Protocol, and equivalent documents through the Document Control system.
- Issuance of document, part, lot, and investigation numbers.
- Issuance and review of electronic and paper-based GMP logbooks.
- Assists with continually evaluating Quality Systems and procedures while independently identifying areas for improvement and assisting in the implementation of new practices.
- Assists with reviewing, processing, and maintaining the training program.
- Provides GMP training to cross-functional departments.
- Coordinate, perform, and track internal audits.
- Coordinate, perform, and track external audits.
- Coordinate, perform, and track risk assessments.
- Assists with customer communication and customer audit processes.
- Writes, reviews, and approves discrepancy reports (e.g. deviations, CAPAs, complaints, etc.).
- Performs regular follow-ups and tracks discrepancy reports to closure.
- Assists with executing and maintaining Electronic Management Systems as it relates to Quality.
- Issue and review labels used for GMP processes.
- Assists with generating and providing Quality metrics for review.
- Performs other related duties as assigned.
- Operates to the highest ethical and moral standards.
- Complies with company¿s policies and procedures.
- Adheres to quality standards set by regulations and company's policies, procedures and mission.
- Communicates effectively with supervisors, colleagues and subordinates.
- Ability to participate effectively as a team player in all aspects of company's business.
- Demonstrate administrative leadership with knowledge-based expertise in related areas that can be applied to meeting company's strategic goals.
- Travels as needed to attend audits, professional conferences, and training opportunities.
- Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company's policies and practices.
- Bachelor's (BS / BA) degree in a relevant life sciences discipline or equivalent.
- Minimum of four (4) to six (6) years' experience in a GMP oriented environment and Quality Assurance.
- Knowledge of GMP regulations, good documentation practices, cGMP, 21CFR, USP and other applicable regulations, standards and guidance.
- Knowledge of industry standards and regulation requirements for biologics and paternal products in clinical development.
- Ability to analyze with proficiency in the application of problem solving and root cause analysis methodologies.
- Skill in writing to effectively communicate complex ideas and concepts.
- Detail oriented with strong analytical, written, and verbal communication skills.
- Must be familiar with Microsoft Office applications.
- Ability to work well under pressure, independently, multi-task, be organized and have good communication skills.
For Immediate Consideration, Apply Today! Questions? Call Alex at 858.207.6311.
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