Job Title: QC Inspector

Responsibilities

• Oversee and confirm compliance in Compounding processes including room clearance, verification of material status, weighing, mixing, and charging of chemicals.
• Ensure compliance with batch record instructions and sequence, and verify documentation.
• Oversee and confirm compliance in Filling Operations, including line clearance, material status, aseptic technique, and in-process quality attribute testing.
• Verify proper gowning by all personnel in all areas of Production.
• Monitor environmental activities including plating, Lighthouse, and personnel monitoring.
• Generate deviations, issue CAPAs, and Change Controls in response to observations.
• Follow up with Quality Assurance Management on quality issue tracking and trending activities.
• Review and approve product labels.
• Participate in regulatory audits.
• Conduct root cause analysis and assist process owners.
• Prepare and monitor Quality Metrics and KPIs.
• Perform duties in accordance with established company procedures and policies.
• Conduct QC inspections of vials for cosmetic and physical defects to support manufacturing.
• Ensure all work is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
• Accurately complete production documentation and maintain logbooks as per SOP requirements.

Essential Skills

• Minimum of 3 years’ experience with aseptic drug product manufacturing.

Additional Skills & Qualifications

• Experience in inspection of vials for cosmetic and physical defects.
• Classification of defects observed during inspection as per related procedures.
• Close visual acuity to notice errors and/or defects and attention to detail.
• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning, and working in sterile and controlled areas.
• Reports any accidents, incidents, injuries, or illnesses immediately and notifies the manager of any hazards, unsafe acts, or conditions in the workplace.

Pay and Benefits

The pay range for this position is $25.00 - $28.00

• 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)

Workplace Type

This is a fully onsite position in LEDGEWOOD,NJ.

Application Deadline

This position will be accepting applications until Dec 11, 2024.

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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people

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.

Salary : $25 - $28