NESCO Inc
QA QMS Lead - Investigations
Overview The QA QMS Lead - Investigations is responsible for leading and managing the investigation process for quality events such as Out of Specification (OOS), Out of Trend (OOT), Deviations, Complaints, and Non-Conformances. This individual ensures root causes are properly identified, corrective and preventive actions (CAPA) are implemented effectively, and all quality systems comply with current Good Manufacturing Practices (cGMP) and regulatory requirements.
Responsibilities Investigations & CAPA Lead the site investigation team for OOS, OOT, Deviations, Complaints, and Non-Conformances. Conduct thorough root cause analyses and prepare detailed investigation reports. Develop, review, and approve CAPA plans to ensure timely and effective resolution of issues. Monitor CAPA implementation and track effectiveness to prevent recurrence. Cross-Functional Collaboration
Partner closely with QA, QC, Operations, Manufacturing, and Engineering departments to gather data and implement corrective actions. Communicate investigation findings and follow-up actions to relevant stakeholders. Change Control & Risk Assessment
Oversee proposed changes to processes, equipment, and systems to ensure they do not adversely affect product quality. Conduct and document risk assessments for changes; implement necessary controls in accordance with regulatory standards. Quality Systems Management
Maintain and improve QMS processes, procedures, and documentation to ensure consistency and compliance. Ensure proper issuance, retrieval, and tracking of QMS documents across the site. Resolve findings from internal and external audits and implement corrective actions as required. Training & Compliance
Conduct training sessions on quality standards, investigation procedures, and best practices. Maintain updated training records to ensure compliance and employee competency. Systems & Tools
Utilize QMS software such as
TrackWise
and
SAP
for managing investigations, CAPAs, and change controls Requirements Education
Bachelor's degree in
Science ,
Pharmacy , or a related field. Experience
5-8 years of relevant experience in
pharmaceutical manufacturing , with a focus on
Quality Assurance
and
Quality Management Systems . Technical Knowledge
Strong understanding of
cGMP ,
CAPA management ,
root cause analysis , and
change control . Proficiency in
QMS software
(TrackWise, MasterControl, etc.). Familiarity with regulatory guidelines such as
CDER ,
ICH ,
CHRA , and
USP Monographs . Skills & Competencies
Strong
technical writing
and documentation skills. Ability to make
independent decisions
regarding investigation outcomes. Excellent
organizational ,
analytical , and
problem-solving
skills. Detail-oriented with the ability to work effectively in a
cross-functional
environment. Self-motivated and capable of working
independently . Working knowledge of
Good Manufacturing Practices (GMP)
and
Good Documentation Practices (GDP) .
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.
Overview The QA QMS Lead - Investigations is responsible for leading and managing the investigation process for quality events such as Out of Specification (OOS), Out of Trend (OOT), Deviations, Complaints, and Non-Conformances. This individual ensures root causes are properly identified, corrective and preventive actions (CAPA) are implemented effectively, and all quality systems comply with current Good Manufacturing Practices (cGMP) and regulatory requirements.
Responsibilities Investigations & CAPA Lead the site investigation team for OOS, OOT, Deviations, Complaints, and Non-Conformances. Conduct thorough root cause analyses and prepare detailed investigation reports. Develop, review, and approve CAPA plans to ensure timely and effective resolution of issues. Monitor CAPA implementation and track effectiveness to prevent recurrence. Cross-Functional Collaboration
Partner closely with QA, QC, Operations, Manufacturing, and Engineering departments to gather data and implement corrective actions. Communicate investigation findings and follow-up actions to relevant stakeholders. Change Control & Risk Assessment
Oversee proposed changes to processes, equipment, and systems to ensure they do not adversely affect product quality. Conduct and document risk assessments for changes; implement necessary controls in accordance with regulatory standards. Quality Systems Management
Maintain and improve QMS processes, procedures, and documentation to ensure consistency and compliance. Ensure proper issuance, retrieval, and tracking of QMS documents across the site. Resolve findings from internal and external audits and implement corrective actions as required. Training & Compliance
Conduct training sessions on quality standards, investigation procedures, and best practices. Maintain updated training records to ensure compliance and employee competency. Systems & Tools
Utilize QMS software such as
TrackWise
and
SAP
for managing investigations, CAPAs, and change controls Requirements Education
Bachelor's degree in
Science ,
Pharmacy , or a related field. Experience
5-8 years of relevant experience in
pharmaceutical manufacturing , with a focus on
Quality Assurance
and
Quality Management Systems . Technical Knowledge
Strong understanding of
cGMP ,
CAPA management ,
root cause analysis , and
change control . Proficiency in
QMS software
(TrackWise, MasterControl, etc.). Familiarity with regulatory guidelines such as
CDER ,
ICH ,
CHRA , and
USP Monographs . Skills & Competencies
Strong
technical writing
and documentation skills. Ability to make
independent decisions
regarding investigation outcomes. Excellent
organizational ,
analytical , and
problem-solving
skills. Detail-oriented with the ability to work effectively in a
cross-functional
environment. Self-motivated and capable of working
independently . Working knowledge of
Good Manufacturing Practices (GMP)
and
Good Documentation Practices (GDP) .
Nesco Resource provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws.