["GMP Compliance & CAPA Specialist","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 gatheringWrite investigation reports to clearly communicate what happened, why it happened, and when it happenedPropose CAPAs to prevent events from recurringDeploy industry-standard Lean and Six Sigma tools to address the root causes of non-conforming quality eventsFacilitate cross-functional problem-solving eventsAuthor SOPs and work instructionsReview investigation documentation for Out Of Specifications, Out Of Trend, or atypical results, as well as deviations from regulations, corporate policy, or site proceduresManage timelines for investigations/complaints to ensure timely reporting and resolutionCommunicate clearly with internal and external clients, both verbally and in writingUnderstand related SOPs and cGMPs necessary to accomplish daily tasksPerform all other duties as assignedPayrate: $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 gatheringWrite investigation reports to clearly communicate what happened, why it happened, and when it happenedPropose CAPAs to prevent events from recurringDeploy industry-standard Lean and Six Sigma tools to address the root causes of non-conforming quality eventsFacilitate cross-functional problem-solving eventsAuthor SOPs and work instructionsReview investigation documentation for Out Of Specifications, Out Of Trend, or atypical results, as well as deviations from regulations, corporate policy, or site proceduresManage timelines for investigations/complaints to ensure timely reporting and resolutionCommunicate clearly with internal and external clients, both verbally and in writingUnderstand related SOPs and cGMPs necessary to accomplish daily tasksPerform all other duties as assignedQualifications: Bachelor's degree requiredMinimum of 5 years of relevant industry experience in a cGMP environment or comparable pharmaceutical knowledge and experienceMinimum of 3 years of technical writing experience such as validation reports, engineering documents, controlled documents (SOPs, Batch Records, Work Instructions) in a GMP environmentDesired Skills: Lean, Six Sigma, SPC experience (1 year preferred)Excellent oral and written communication skillsProactive problem-solving and analytical skillsSelf-motivated, disciplined, focused, work well under pressure, and able to prioritize workAbility to simultaneously work on several projects with the flexibility to reprioritize quicklyStrong 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.Consent to Communication and Use of AI Technology: By submitting your application for this positionand providing your email address(es) and/or phone number(s), you consent to receive text (SMS), email, and/or voice communication whether automated(including auto telephone dialing systems or automatic text messaging systems), pre-recorded,AI-assisted, or individually initiated from Aditi Consulting, our agents, representatives, or affiliatesat the phone number and/or email address you have provided. These communications may include information about potential opportunities and information. Message and data rates may apply. 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