Description
\t\t\t\t\t•\tProvides Quality oversight of Production activities, including compounding, aseptic filling, inspection, and labeling/packaging on the floor.•\tProvides Quality oversight of cleaning activities to ensure compliance with cleaning requirements. •\tProduct label review and approval. •\tOversight and confirmation compliance with Filling Operations, including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms, and batch records. •\tVerification of proper gowning by all personnel in all areas of Production.•\tGeneration of deviations, issuance of CAPAs, and Change Controls in response to observations.•\tOversee all Quality aspects on the floor.•\tParticipate in regulatory audits if required. •\tPerforms or assists process owners with the root cause analysis.•\tResponsible for generating deviations and change controls when required. •\tPerforms duties following established company procedures and policies; performs other duties as assigned. 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 observationsFollow 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 floorProduct label review and approvalParticipate in regulatory auditsPerforms or assists process owners with root cause analysisPrepares and monitors Quality Metrics and KPI’sPerforms duties in accordance with established company procedures and policies; performs other duties as assigned.
\t\t\t\t\tSkills
\t\t\t\t\tQuality assurance, Qa testing, sop, Gmp, Aseptic technique, Fda, Quality control, Inspection, Qa, Quality check, Batch record, Cgmp, Batch record review
\t\t\t\t\tTop Skills Details
\t\t\t\t\tQuality assurance,Qa testing,sop,Gmp,Aseptic technique,Fda
\t\t\t\t\tAdditional Skills & Qualifications
\t\t\t\t\t•\t3-5 years of progressive experience in cGMP quality operations and FDA regulations, a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment, or equivalent technical experience.•\tBS in the Scientific field preferred•\tThree-plus years of experience with aseptic drug product manufacturing is required.•\tA fundamental, working knowledge of safety, quality systems, and quality assurance concepts are required, including the application of current Good Manufacturing Practices and Good Documentation Practices.•\tStrong familiarity with manufacturing processes, operations, automation, and equipment/facilities.•\tAbility to complete tasks with little direction or need for supervisory follow-up.•\tStrong written, verbal, and presentation communication skills.•\tStrong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and others must be able to learn additional software as required).•\tAbility to think creatively in confronting new issues and pursuing novel approaches to old problems.•\tAbility to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.•\tWork schedule flexibility.
\t\t\t\t\tExperience Level
\t\t\t\t\tIntermediate Level
Pay and Benefits
The pay range for this position is $25.00 - $30.00/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 Sep 16, 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.
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 due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.