QC Inspection Specialist
Responsibilities
- Manage the lifecycle of computerized systems in a regulated pharmaceutical manufacturing environment, ensuring ongoing compliance and validated state.
- Lead and support computerized system validation (CSV) activities for manufacturing, laboratory, and automation systems.
- Author, review, and execute IQ/OQ/PQ protocols and other validation documentation for equipment, systems, and processes.
- Develop, implement, and maintain validation procedures, policies, and standards aligned with cGMP requirements.
- Support equipment qualification, system implementation, and change control activities, including documentation and execution.
- Conduct risk assessments, gap analyses, and traceability exercises to identify and mitigate validation and compliance risks.
- Review, revise, and update standard operating procedures (SOPs) and manufacturing process documentation to reflect validated states and regulatory expectations.
- Collaborate with Quality, Engineering, Manufacturing, Facilities, and Operations teams to plan, coordinate, and execute validation projects.
- Support CAPA investigations by contributing to root cause analysis, defining corrective and preventive actions, and maintaining validated status of systems and equipment.
- Absorb and prepare clear and comprehensive validation reports, discrepancy reports, and technical documentation to support regulatory and quality requirements.
- Assist with internal and external audits and inspections by preparing documentation, addressing findings, and supporting compliance initiatives.
- Prepare and conduct visual inspection and QC activities related to production and laboratory processes, ensuring product and process quality.
- Promote quality assurance best practices across production, laboratory, and inspection activities, reinforcing adherence to cGMP and internal standards.
Requirements
- Bachelor's degree in Engineering, Science, Computer Science, Software Engineering, Chemistry, or a closely related field.
- At least 5 years of validation experience in a pharmaceutical or manufacturing environment.
- Demonstrated experience working within cGMP-regulated environments and applying regulatory guidance to daily operations.
- Hands-on experience with computerized system validations (CSV) in manufacturing or laboratory settings.
- Strong technical writing and documentation skills, including authoring protocols, reports, and SOPs.
- Proficiency with Microsoft Office applications for documentation, data analysis, and reporting.
- Experience working with quality assurance processes, QC inspection, SOP development, and production support in a regulated environment.
Qualifications
- Experience validating laboratory or manufacturing equipment, including automation systems.
- Knowledge and practical experience with IQ/OQ/PQ execution for equipment and computerized systems.
- Familiarity with CAPA, Change Control, and Risk Assessment processes in a pharmaceutical or manufacturing context.
- Experience with pharmaceutical manufacturing equipment and related laboratory systems.
- Strong project coordination skills, including planning, prioritizing, and tracking validation activities.
- Effective stakeholder management skills with the ability to collaborate across Quality, Engineering, Manufacturing, Facilities, and Operations.
- Exposure to visual inspection, laboratory QC, and production processes in a pharmaceutical setting.
Skills
- Technical writing and documentation skills.
- Microsoft Office proficiency.
- Quality assurance best practices.
- Collaboration and stakeholder management.
- Validation and compliance processes.
Benefits
Eligible for benefits such as medical and dental coverage, retirement savings options, and discounted gym memberships. The environment emphasizes compliance, safety, and continuous improvement, with expectations for professional attire appropriate to a pharmaceutical manufacturing and laboratory setting.
Pay and Benefits
The pay range for this position is $28.00 - $32.00/hr. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision, Critical Illness, Accident, and Hospital, 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available, Life Insurance (Voluntary Life & AD&D for the employee and dependents), Short and long-term disability, Health Spending Account (HSA), Transportation benefits, Employee Assistance Program, Time Off/Leave (PTO, Vacation or Sick Leave).
About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service. The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.