Job Description
Execute tasks per CGMP guidelines and Standard Operating Procedures to manufacture, inspect, and package Anthrax Vaccine Adsorbed. Complete training and maintain competence per the manufacturing training program. Actively incorporate the Shared Values while performing day-to-day activities.
ResponsibilitiesComplete training and demonstrate competency on Assistant Manufacturing Associate qualification blocks in accordance with the training progression pathway.Execute and document procedural steps in compliance with CGMP standards, clean room behavior, and Standard Operating Procedures.Comply with all applicable rules and regulations including FDA regulations such as CGMP, GDP, EH&S regulations, and company regulations such as the employee handbook.Maintain state of facility environmental control including preparation of defined concentrations of cleaning solutions, daily, monthly, quarterly, and annual cleaning of manufacturing areas per Standard Operating Procedures.Review all documentation for accuracy and completeness of process signature steps as each step is completed. Perform 'real time' review of all documentation (BPRs, forms, logs, etc.) in the area throughout the shift.Stock gowning and consumable supplies in the controlled areas maintaining Kanban inventory control of manufacturing materials.Successfully complete inspector qualification requirements to identify, classify, and cull product defects, including those defects which could impact patient safety (inspector qualification).Independently operate labeling equipment with minimal supervision.Apply traceability and expiration information to secondary packaging components such as cartons and cases. Confirm suitability of secondary packaging components during printing processes through 100% inspection (carton printing, case creation).Package product in secondary and final packaging components while performing 100% reconciliation of product rejects.Complete ambient tracking documentation.Execute material issuance and confirmation of process steps using specific SAP modules.Essential SkillsProductionGMPPackagingAseptic techniqueBatch recordAsepticAdditional Skills & QualificationsInspection of vials visually.Cartoning the vials.Weighing chemicals and hydrations.Work Environment
This role will take place in a cGMP facility. The packaging area is Grade D spaces and inspection will be in Grade C spaces. This is a Monday to Thursday role from 6 am to 4:30 pm. The culture is very strong, with respect for co-workers being paramount. Teamwork and winning together are very important as the company is entering growth mode.
Pay and Benefits
The pay range for this position is $16.92 - $19.83/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 Lansing,MI.
Application Deadline
This position is anticipated to close on Feb 14, 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 & InclusionAt 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 peopleThe 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.