Top 3 Must Have Skill Sets:
1.Responsible for providing Quality oversight to ensure that operations for licensed pharmaceutical products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP) and other applicable regulations
2.Ensures that facilities, equipment, materials, organization, processes, procedures and products comply with cGMP practices and other applicable regulations
3. Performs review, approval and tracking of cGMP processes, procedures, assays, documents and records, including but not limited to deviations, CAPAs, and validations
The Senior Associate Quality Assurance will be accountable for Quality On-the-Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during operations to facilitate real-time decision-making regarding quality requirements and deviations. This is a unique opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff. Quality Assurance On-the-Floor provides mentoring, guidance and direction to Manufacturing, Quality Control and Facilities & Engineering staff in regards to compliance and quality systems.
Scientific degree in Life Sciences, Physical Sciences, Applied Engineering or Manufacturing Technologies
Bachelor’s degree and 2 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience, OR
Associate’s degree and 6 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience, OR
High school diploma / GED and 8 years of Quality, Manufacturing, Validation, Process Development or Process Engineering experience.
Previous QA oversight of manufacturing, analytical and engineering activities
"This posting is for Contingent Worker, not an FTE"