GMP Compliance & CAPA Specialist

Aditi Consulting; San Diego (CA); On-site; USD 48,870 - 69,603; Full time

Benefits offered by this job

Medical benefits

401(k) plan with employer match

10 paid days off

Life and disability insurance

Job summary

A leading consulting firm is looking for a Quality Assurance Specialist to ensure patient safety and regulatory compliance. The role involves leading investigations, managing deviations, and using Lean and Six Sigma tools. Candidates must have a Bachelor's degree and at least 5 years of experience in a cGMP environment. Responsibilities include writing investigation reports, proposing corrective actions, and facilitating problem-solving sessions. Positions offer competitive pay and comprehensive benefits including medical, dental, and a 401(k) plan.

Qualifications

• 5+ years of relevant industry experience in a cGMP environment.
• 3 years of technical writing experience in a GMP environment.

Responsibilities

• Facilitate Rapid Response Team fact gathering.
• Write investigation reports to communicate findings.
• Propose CAPAs to prevent event recurrence.
• Deploy Lean and Six Sigma tools for root cause analysis.
• Manage timelines for investigations and communicate with clients.

Skills

Lean Six Sigma

Excellent communication skills

Problem-solving skills

Analytical skills

Proficiency in MS Office

Education

Bachelor’s degree

Tools

MS Office

Job description

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 40 in a work week, or as required by state or local law. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, health savings accounts with qualified medical plan enrollment, 10 paid days off, 3 days paid bereavement leave, 401(k) plan participation with employer match, life and disability insurance, commuter benefits, dependent care flexible spending account, accident insurance, critical illness insurance, hospital indemnity insurance, accommodations and reimbursement for work travel, and discretionary performance or recognition bonus. Sick leave and mobile phone reimbursement provided based on state or local law.

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