QA CAPA Investigations Specialist

Pinnaql, Inc.; United States; On-site; USD 85,000 - 120,000; Full time

Job summary

Validation & Engineering Group is seeking a QA CAPA Investigation Specialist to support quality investigations within a regulated manufacturing environment. The role involves conducting and documenting CAPAs, nonconformances and related quality events, performing root cause analysis, and collaborating with cross-functional teams to ensure timely, well-documented resolutions.

Responsibilities include gathering data, preparing robust investigation reports, supporting corrective/preventive actions,

Qualifications

• Bachelor's degree in Engineering, Science, Quality, Manufacturing or a related technical discipline
• Typically 35 years of experience in Quality Assurance, Quality Compliance, Investigations, CAPA or a related function within an FDA regulated industry
• Hands on experience conducting or supporting CAPAs, deviations, nonconformances or quality investigations
• Working knowledge of structured root cause analysis and problem solving methodologies
• Strong technical writing and documentation skills
• Strong analytical and organizational skills
• Ability to manage multiple investigations and priorities simultaneously
• Effective written and verbal communication skills
• Ability to work collaboratively with cross functional teams

Responsibilities

• Conduct and document quality investigations, CAPAs, nonconformances and related quality events
• Gather and analyze relevant data records and supporting documentation
• Perform structured root cause analysis using 5 Whys, Fishbone/Ishikawa and other problem solving methodologies
• Identify root causes, contributing factors and potential systemic issues
• Prepare clear, accurate and technically sound investigation reports
• Support the development and implementation of corrective and preventive actions
• Track assigned CAPA and investigation activities through completion
• Support effectiveness checks to verify that implemented actions achieved the intended results
• Collaborate with cross functional stakeholders to obtain information, resolve open items and complete investigations within established timelines
• Review supporting documentation to ensure conclusions are based on objective evidence and appropriate technical rationale
• Assist with trend analysis and identification of recurring quality issues
• Support audit and regulatory inspection readiness activities as needed
• Maintain complete and timely documentation in accordance with applicable procedures and regulatory requirements

Skills

Root cause analysis

CAPA investigations

Technical writing

Cross-functional collaboration

Analytical skills

Organizational skills

Multi-task management

Verbal and written communication

Education

Bachelors degree in Engineering Science Quality Manufacturing or related technical discipline

Job description

Validation & Engineering Group Inc V&EG a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas Laboratory Compliance Computer Engineering Project Management Validation and other services We are seeking a QA CAPA Investigation Specialist to support quality investigation and corrective action activities within a regulated manufacturing environment The successful candidate will be responsible for conducting and documenting investigations supporting Corrective and Preventive Action activities performing root cause analysis and collaborating with cross functional teams to ensure quality issues are thoroughly evaluated appropriately documented and effectively resolved.

Description

• Conduct and document quality investigations CAPAs nonconformances and related quality events
• Gather and analyze relevant data records and supporting documentation
• Perform structured root cause analysis using tools such as 5 Whys FishboneIshikawa and other problem solving methodologies
• Identify root causes contributing factors and potential systemic issues
• Prepare clear accurate and technically sound investigation reports
• Support the development and implementation of corrective and preventive actions
• Track assigned CAPA and investigation activities through completion
• Support effectiveness checks to verify that implemented actions achieved the intended results
• Collaborate with cross functional stakeholders to obtain information resolve open items and complete investigations within established timelines
• Review supporting documentation to ensure conclusions are based on objective evidence and appropriate technical rationale
• Assist with trend analysis and identification of recurring quality issues
• Support audit and regulatory inspection readiness activities as needed
• Maintain complete and timely documentation in accordance with applicable procedures and regulatory requirements

Qualifications

• Bachelors degree in Engineering Science Quality Manufacturing or a related technical discipline
• Typically 35 years of experience in Quality Assurance Quality Compliance Investigations CAPA or a related function within an FDA regulated industry
• Hands on experience conducting or supporting CAPAs deviations nonconformances or quality investigations
• Working knowledge of structured root cause analysis and problem solving methodologies
• Strong technical writing and documentation skills
• Strong analytical and organizational skills
• Ability to manage multiple investigations and priorities simultaneously
• Effective written and verbal communication skills
• Ability to work collaboratively with cross functional teams

Preferred Qualifications

• Experience in medical device pharmaceutical or other regulated manufacturing environments
• Familiarity with applicable FDA regulations and GMP requirements
• Experience with risk assessment tools such as FMEA
• Experience using electronic Quality Management Systems
• Lean Six Sigma or Quality related training is a plus

At Validation & Engineering Group people always come first We believe that when youre empowered to do your best work bold ideas thrive and real progress happens This isnt just a job its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose driven supportive team Excited to build something meaningful together We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status LI LN1 LI ONSITE