Principal Quality Assurance Reviewer

About the role

Independently reviews and approves: Investigations into non-conformances and proposed actions to prevent reoccurrences in support of manufacturing operations
Laboratory investigations into out of specification (OOS) and out of trend (OOT) results
Supplier corrective action requests and proposed vendor actions
Coaches investigation team to enable preparation of investigation reports that include recommendations on investigation findings for medium/high severity non-conformances
Analyzes and evaluates information captured through investigations, summarizes information and trends in investigation reports
Presents quality considerations and recommendations at group meetings with multiple levels of management
Reviews primary data sources to assure the accuracy of investigative conclusions in accordance with cGMP standards in support of investigations
Provides quality reviews and oversight on a wide range of investigations of differing subject matter
Monitors production processes and quality systems data to acquire vital data in support of investigations and track efficiency of changes
Participates in and/or leads cross-functional study teams to get results
Captures, trends and analyzes process related data to drive consistency and timeliness
Trains employees on investigative processes and techniques
Captures, trends and analyzes process related data to drive consistency and timeliness
Captures, trends and analyzes process related data to drive consistency and timeliness

Responsibilities

• Independently reviews and approves: Investigations into non-conformances and proposed actions to prevent reoccurrences in support of manufacturing operations
• Laboratory investigations into out of specification (OOS) and out of trend (OOT) results
• Supplier corrective action requests and proposed vendor actions
• Coaches investigation team to enable preparation of investigation reports that include recommendations on investigation findings for medium/high severity non-conformances
• Analyzes and evaluates information captured through investigations, summarizes information and trends in investigation reports
• Presents quality considerations and recommendations at group meetings with multiple levels of management
• Reviews primary data sources to assure the accuracy of investigative conclusions in accordance with cGMP standards in support of investigations
• Provides quality reviews and oversight on a wide range of investigations of differing subject matter
• Monitors production processes and quality systems data to acquire vital data in support of investigations and track efficiency of changes
• Participates in and/or leads cross-functional study teams to get results
• Captures, trends and analyzes process related data to drive consistency and timeliness
• Trains employees on investigative processes and techniques

Requirements

• BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
• Principal QA Specialist: 8+ years of relevant experience
• Staff QA Specialist: 10+ years of relevant experience
• Experience with sterile drug product manufacturing, fill finish and/or quality control testing

Qualifications

• BS/BA in Life Sciences, Engineering or related field; or equivalent combination of education and experience
• 8+ years of relevant experience for Principal QA Specialist
• 10+ years of relevant experience for Staff QA Specialist
• Experience with sterile drug product manufacturing, fill finish and/or quality control testing

Skills

• Strong analytical and problem-solving skills
• Excellent communication and interpersonal skills
• Ability to work independently and as part of a team
• Knowledge of cGMP standards

Benefits

• Competitive and comprehensive total rewards package including annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits

Pay

$92,200.00 - $176,000.00 annually

Schedule

Monday-Friday, 8am-4:30pm