GMP Compliance & CAPA Specialist

Payrate: $43.00 - $43.00/hr.

Summary:
The role ensures patient safety, regulatory compliance, and inspection readiness by leading investigations and managing deviations and complaints with precision and accountability. The specialist facilitates Rapid Response Team fact-gathering, authors clear and comprehensive investigation reports, and proposes effective Corrective Action, Preventative Actions (CAPA’s) to prevent recurrence of quality events. Leveraging industry-standard Lean and Six Sigma tools, the specialist drives root cause analysis, leads cross-functional problem-solving sessions, and develops SOPs and work instructions to strengthen operational standards.

Responsibilities:

• Participate in and facilitate Rapid Response Team fact gathering
• Write investigation reports to clearly communicate what happened, why it happened, and when it happened
• Propose CAPAs to prevent events from recurring
• Deploy industry-standard Lean and Six Sigma tools to address the root causes of non-conforming quality events
• Facilitate cross-functional problem-solving events
• Author SOPs and work instructions
• Review investigation documentation for Out Of Specifications, Out Of Trend, or atypical results, as well as deviations from regulations, corporate policy, or site procedures
• Manage timelines for investigations/complaints to ensure timely reporting and resolution
• Communicate clearly with internal and external clients, both verbally and in writing
• Understand related SOPs and cGMPs necessary to accomplish daily tasks
• Perform all other duties as assigned

Payrate: $43.00 - $43.00/hr.

Summary:
The role ensures patient safety, regulatory compliance, and inspection readiness by leading investigations and managing deviations and complaints with precision and accountability. The specialist facilitates Rapid Response Team fact-gathering, authors clear and comprehensive investigation reports, and proposes effective Corrective Action, Preventative Actions (CAPA’s) to prevent recurrence of quality events. Leveraging industry-standard Lean and Six Sigma tools, the specialist drives root cause analysis, leads cross-functional problem-solving sessions, and develops SOPs and work instructions to strengthen operational standards.

Responsibilities:

• Participate in and facilitate Rapid Response Team fact gathering
• Write investigation reports to clearly communicate what happened, why it happened, and when it happened
• Propose CAPAs to prevent events from recurring
• Deploy industry-standard Lean and Six Sigma tools to address the root causes of non-conforming quality events
• Facilitate cross-functional problem-solving events
• Author SOPs and work instructions
• Review investigation documentation for Out Of Specifications, Out Of Trend, or atypical results, as well as deviations from regulations, corporate policy, or site procedures
• Manage timelines for investigations/complaints to ensure timely reporting and resolution
• Communicate clearly with internal and external clients, both verbally and in writing
• Understand related SOPs and cGMPs necessary to accomplish daily tasks
• Perform all other duties as assigned

Qualifications:

• Bachelor’s degree required
• Minimum of 5 years of relevant industry experience in a cGMP environment or comparable pharmaceutical knowledge and experience
• Minimum of 3 years of technical writing experience such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GMP environment

Desired Skills:

• Lean, Six Sigma, SPC experience (1 year preferred)
• Excellent oral and written communication skills
• Proactive problem-solving and analytical skills
• Self-motivated, disciplined, focused, work well under pressure, and able to prioritize work
• Ability to simultaneously work on several projects with the flexibility to reprioritize quickly
• Strong knowledge of MS Office software and query-based systems activities (e.g., Pivot Tables, VLOOKUP’s, Excel Formulas, building presentations in PowerPoint, etc.)

Pay Transparency: The typical base pay for this role across the U.S. is:$43.00 - $43.00/hour. Non-exempt positions are eligible for overtime at a rate of 1.5 times the base hourly rate for all hours worked in excess of…