Job Title: QC Inspector

Job Description

Oversight and confirmation of compliance in Compounding processes including room clearance, verification of material status, weighing, mixing, charging of chemicals, in-process quality attributes, autoclave, compliance with batch record instructions and sequence, documentation verification, logbook documentation verification. Oversight and confirmation in compliance of Filling Operations including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms and batch records. Verification of proper gowning by all personnel in all areas of Production. Verification of environmental monitoring activities including plating, Lighthouse and personnel monitoring. Generation of deviations, issuance of CAPAs, Change Controls in response to observations. Follow up with Quality Assurance Management on quality issue tracking and trending activities also include batch record review, batch release, visual inspection and any other activity assigned by Quality Assurance management. Oversee all Quality aspects on the floor. Product label review and approval. Participate in regulatory audits. Performs or assists process owners with root cause analysis. Prepares and monitors Quality Metrics and KPIs. Performs duties in accordance with established company procedures and policies; performs other duties as assigned.

Responsibilities

• Conduct QC inspections of vials for cosmetic and physical defects to support manufacturing.
• Oversee and confirm compliance in Compounding processes including room clearance, verification of material status, weighing, mixing, charging of chemicals, in-process quality attributes, and autoclave.
• Ensure compliance with batch record instructions and sequence, documentation verification, and logbook documentation verification.
• Oversee Filling Operations including line clearance, material status, aseptic technique, in-process quality attribute testing, and documentation on forms and batch records.
• Verify proper gowning by all personnel in all areas of Production.
• Verify environmental monitoring 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 release batch records, conduct visual inspections, and perform other activities assigned by Quality Assurance management.
• Oversee all Quality aspects on the floor.
• Review and approve product labels.
• Participate in regulatory audits.
• Assist process owners with root cause analysis.
• Prepare and monitor Quality Metrics and KPIs.
• Ensure all work is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
• Accurate completion of production documentation and all appropriate logbooks.
• Maintain cleaning logs per SOP requirements.
• Report any accidents, incidents, injuries, or illnesses immediately and notify the manager of any hazards, unsafe acts, or conditions in the workplace.

Essential Skills

• 3 plus years’ experience with aseptic drug product manufacturing.
• Fundamental knowledge of safety, quality systems, and quality assurance concepts including the application of current Good Manufacturing Practices and Good Documentation Practices.
• Strong familiarity with manufacturing process and operations, automation, and equipment/facilities validation.
• Familiarity with FDA inspections and audits.
• Investigation writing skills.
• Ability to complete tasks with little direction or need for supervisory follow-up.
• Strong written, verbal, and presentation communication skills.
• Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel) and the ability to learn additional software as required.
• Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
• Ability to work under pressure, meet deadlines, and exercise sound business judgment with critical thinking skills and high ethical standards.
• Close visual acuity to notice errors and/or defects and attention to detail.
• Knowledge of current Good Manufacturing Practices (cGMP) guidelines.

Additional Skills & Qualifications

• Experience with Quality Assurance and gowning procedures.
• Experience in production oversight.
• Experience conducting QC inspections in ISO7, ISO8, and other classified areas.

Work Environment

25 people on the QA team. Will be working in 503B clean rooms. Shift: Part Time (30 hours per week). Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning, and working in sterile and controlled areas.

Pay and Benefits

The pay range for this position is $24.00 - $25.00/hr.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. 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)

Workplace Type

This is a fully onsite position in Ledgewood,NJ.

Application Deadline

This position is anticipated to close on Mar 21, 2025.

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 : $24 - $25