Quality Assurance Specialist-III

AllSTEM Connections; Camarillo (CA); On-site; USD 70,000 - 90,000; Full time

Job summary

A leading pharmaceutical company in California is seeking a skilled professional to perform complex testing and data evaluation. This role requires a Bachelor's Degree in Chemistry or related field and a minimum of 5 years of relevant experience. Responsibilities include executing and reviewing standard operating procedures and coordinating with external labs. Candidates should have a thorough understanding of regulatory compliance and be capable of leading departmental projects and teams.

Qualifications

• Minimum 5 years of relevant pharmaceutical experience.

Responsibilities

• Perform complex testing and data evaluation.
• Execute, author, and review SOPs and reports.
• Coordinate testing performed at outside labs.
• May lead stability program management.

Skills

Liquid/Gas Chromatography

Data evaluation

Troubleshooting

Regulatory compliance

Data management systems

Education

Bachelor's Degree in Chemistry or related field

Job description

Qualifications

• Bachelor's Degree in Chemistry or related field
• Minimum 5 years of relevant pharmaceutical experience

Responsibilities

• Perform complex testing and data evaluation
• Perform complex Liquid/Gas Chromatography, UPLC, and other testing, and, as needed, troubleshoot issues
• Participate in or assist with test method validations
• Support supervisors in OOS Investigations and complete CAPA requirements
• Interact with outside departments including attending meetings, providing updates, etc.
• Coordinate testing performed at outside testing labs, raw materials, etc.
• Maintain a detailed and accurate recording of activities and results on paperwork
• Execute, author, and review SOPs, reports, protocols, investigations, change controls, and data summaries. Understand and use basic risk assessment and root cause tools
• Train upon and understand methods, equipment and standard operating procedures
• Provide training to others as needed. Attend internal and external training on related subjects, including both intra- and inter-departmental cross-training on new techniques and procedures
• Prepare and order supplies, as necessary
• Enter data into relevant data management systems. Perform tracking and trending of data as requested. Compile data and provide data summaries to management
• Utilize a thorough understanding of regulatory and compliance guidelines for the pharmaceutical industry
• Interact with other departments within the company for testing needs and scheduling
• May lead departmental projects with the opportunity to participate in or lead cross-functional teams, including continuous improvement projects and new customer teams
• May lead stability program including management of test points, reporting of data, and investigations of out of specification or aberrant stability results