Kelly Science, Engineering, Technology & Telecom
QA Validation Specialist (Contract)
Kelly Science, Engineering, Technology & Telecom, Irvine, California, United States, 92713
We are seeking a skilled
QA Validation Specialist (Contract)
to join a leading pharmaceutical team supporting critical
cGMP qualification and validation activities.
This
6‑month contract
offers
$38–40/hr.
and hands‑on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit‑ready execution.
RESPONSIBILITIES:
Assists in assuring facility, manufacturing, packaging, and laboratory equipment are qualified to the required cGMP standards.
Authors/approves and executes qualification protocols and reports.
Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory instruments in coordination with operations, Quality Control and maintenance.
Assists sourcing and procurement of facility equipment and laboratory instruments through completion of following tasks
Qualification of vendors selected.
Input to the development of the URS/FRS/DDS.
Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
May present qualification studies to regulatory and client auditors as required.
Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the production and quality functional areas.
Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
Initiates and investigates exception reports and non-conformances associated with the qualification studies. Troubleshoots and resolves technical issues.
Other responsibilities and special projects will be assigned based on business and customer needs.
QUALIFICATIONS:
Bachelor’s degree in Sciences
5+ years of experience in a highly regulated pharmaceutical industry or related field
Demonstrated experience with qualification of commercial processing and packaging equipment
Proven track record of managing projects from start to finish on time and on budget.
Strong working knowledge of cGMP and regulatory standards for validation.
Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
Seniority Level Associate
Employment Type Contract
Job Function Science, Consulting, and Quality Assurance
Industries Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr
QA Validation Specialist (Contract)
to join a leading pharmaceutical team supporting critical
cGMP qualification and validation activities.
This
6‑month contract
offers
$38–40/hr.
and hands‑on ownership of equipment, facility, and laboratory validations. Ideal for experienced validation professionals who excel in regulated environments and enjoy driving projects from protocol development through audit‑ready execution.
RESPONSIBILITIES:
Assists in assuring facility, manufacturing, packaging, and laboratory equipment are qualified to the required cGMP standards.
Authors/approves and executes qualification protocols and reports.
Schedules, plans, manages performance qualifications, calibration and maintenance of equipment and utility systems and laboratory instruments in coordination with operations, Quality Control and maintenance.
Assists sourcing and procurement of facility equipment and laboratory instruments through completion of following tasks
Qualification of vendors selected.
Input to the development of the URS/FRS/DDS.
Assists with the routine calibration and maintenance of the Validation Master Plan for the site.
May present qualification studies to regulatory and client auditors as required.
Assists with the design, maintenance, and continual improvement of the qualification system in line with cGMP standards.
Provides technical expertise and guidance on qualification policies and procedures and the implementation of those within the production and quality functional areas.
Occasionally supervises specialized contract personnel and outside vendors in the performance of contract services.
Summarizes studies and authors qualification reports in compliance with the cGMP standards and in a timely manner.
Develops and executes matrix type validations where applicable for processes and equipment with adequate supporting rationales.
Initiates and investigates exception reports and non-conformances associated with the qualification studies. Troubleshoots and resolves technical issues.
Other responsibilities and special projects will be assigned based on business and customer needs.
QUALIFICATIONS:
Bachelor’s degree in Sciences
5+ years of experience in a highly regulated pharmaceutical industry or related field
Demonstrated experience with qualification of commercial processing and packaging equipment
Proven track record of managing projects from start to finish on time and on budget.
Strong working knowledge of cGMP and regulatory standards for validation.
Experience in writing and reviewing SOPs, GMPs, governmental regulations and/or protocols for accuracy, traceability and compliance.
Seniority Level Associate
Employment Type Contract
Job Function Science, Consulting, and Quality Assurance
Industries Pharmaceutical Manufacturing
Benefits
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr