Sr Associate QA - Days

About the role

In this vital role you will be responsible for Plant Quality Assurance (PQA) On the Floor in support of Manufacturing activities. This position provides the opportunity to work directly with Manufacturing staff during bulk drug substance operations to facilitate real-time decision-making regarding quality requirements. This is an outstanding opportunity to foster a positive relationship and learning environment between Manufacturing and Quality staff, and also to provide coaching, guidance and direction to Manufacturing, Quality Control, and Facilities/Engineering staff regarding compliance and quality systems.

Responsibilities

• Provide Quality oversight to ensure that products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Distribution Practices (GDP), and other applicable regulations
• Provide Quality oversight during on-the-floor analytical testing
• Ensure that facilities, equipment, materials, processes, and procedures follow cGMPs and other applicable regulations
• Ensure that deviations from established procedures are investigated and documented per procedures
• Ensure that production records and testing results are complete, accurate, and documented according to written procedures and cGMP requirements
• Perform review and approval of cGMP processes, procedures, and records, including but not limited to, Standard Operating Procedures (SOPs), batch records, deviations, and logbooks
• Author, review, and approve quality documents such as risk assessments, training materials, engineering documents, automation documents, protocols, and reports
• Alert senior management of potential quality, compliance, supply, or safety risks
• Complete assigned training to permit execution of required tasks
• Drive operational improvement initiatives, programs, and projects
• Perform other tasks, as assigned, to assist in completion of activities associated with meeting group, departmental, and company goals

Qualifications

Basic Qualifications

• High school/GED + 4 years Quality Assurance or manufacturing work experience OR
• Associates + 2 years Quality Assurance or manufacturing work experience OR
• Bachelors + 6 months Quality Assurance or manufacturing work experience

Preferred Qualifications

• Experience working in a cGMP environment
• Experience with decision making
• Experience with analytical testing and/or general compendia testing
• Experience working with batch records and other GMP documentation
• Knowledge of data integrity requirements
• Proficient in Microsoft Office (e.g., Outlook, Word, Excel, PowerPoint, MS Teams)

Benefits

• A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
• A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
• Stock-based long-term incentives
• Award-winning time-off plans
• Flexible work models where possible

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.