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Contract Duration: 5-18 months
Rate: Negotiable
Salary: NA $1.00
Responsibilities:
Excellent employment opportunity for a QA Specialist - I in the San Dimas, CA area. Provide on the floor QA oversight and support to ensure compliance of GMP activities throughout the site. Direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address compliance issues and questions real time. Ensures adherence to proper escalation when non-conformances are identified as outlined per applicable procedures. Serves as a resource for compliance, escalation and corrections. Ensure departmental compliance to procedures, gmp records and associated forms. Ensures documentation is recorded in accordance with ALCOA principles. Work with operating entities with guidance from senior colleagues to ensure that inspections, statistical processes control analyses and audits are conducted on a continuing basis as specified to enforce requirements and meet specifications. May assist with investigations and corrective and preventive actions (CAPA). Experience:
2+ years of relevant experience in a GMP environment related field and a BS. 3+ years of relevant experience and an AA degree. Demonstrates basic knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs). Demonstrates basic knowledge of FDA standards and quality systems. Demonstrates good verbal, written, and interpersonal communication skills. Demonstrates working knowledge in Microsoft Office applications. Demonstrates basic knowledge of FDA standards and quality systems. Biopharmaceutical or Pharmaceutical experience preferred. Shift Hours: Thurs - Sat (4PM - 4AM) ; Every other Sunday (4PM - 4AM)
Compétences linguistiques
- English
Avis aux utilisateurs
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