Production Technician III - ILP

QuVa - Advancing Healthcare Possibilities; Bloomsbury (NJ); Sur place; USD 28 000 - 39 000; Plein temps

Résumé du poste

QuVa - Advancing Healthcare Possibilities is seeking a Production Technician III – ILP to support visual inspection, labeling and packaging in a GMP-compliant facility in the United States. The role requires experience in pharmaceutical manufacturing and adherence to cGMPs and ISO standards.

The candidate will perform material prep, equipment calibration checks, and documentation, while ensuring safety and regulatory compliance.

Qualifications

• High school Diploma or GED from recognized institution or organization required.
• Minimum of 2 years reliable and sustained performance as a Production Technician II – ILP or pharmaceutical manufacturing experience.
• Legally authorized to work in the job posting country.
• Color perception exam required and must pass.
• Vision exam required and must have 20/20 vision with or without correction.

Responsabilités

• Support ILP operation, including visual inspection, labeling, and packaging.
• Prepare inspection and packaging room materials and supplies.
• Safely transport product and materials per SOP and EH&S requirements.
• Conduct labeling and processing of production materials as required.
• Investigate and resolve reconciliation issues to progress batches toward closure.
• Daily/bi-weekly/monthly cleaning and preventive maintenance documentation.
• Complete line and room clearances per procedures.
• Document activities per GDPs; comply with cGMPs and ISO standards.
• Maintain daily supply list and coordinate with receiving.

Connaissances

Communication skills

Mechanical aptitude

Attention to detail

Flexibility

Safety mindset

Formation

High school diploma or GED

Outils

PacMac equipment

Labelers

Description du poste

The Production Technician III – ILP position is responsible for supporting the execution of product visual inspection, labeling, and packaging (ILP) operations at the Quva facility in accordance with established processes and procedures. At Quva, you will be an essential part of a mission-driven organization dedicated to expanding critical access to quality, affordable medication and data insights while promoting a culture of innovation, collaboration, and continuous improvement.

Key Duties and Responsibilities:

Will directly support the ILP operation, to include but not limited to:

• Visual Inspection of product or label printing operations
• Assist preparation of inspection and packaging room materials supplies
• Safely transport product and materials from warehouse to designated areas in accordance with Standard Operating Procedures (SOP) and EH&S requirements
• Conduct labeling and the processing of production materials as required
• Investigate and resolve reconciliation issues to advance batches towards closure.
• Daily/ Bi-Weekly/Monthly cleaning of room and equipment and fill out appropriate preventative maintenance forms and checklists in accordance with SOP’s
• Conduct and complete line and room clearances as per established procedures
• Complete necessary documents for accountability and traceability of product following Good Documentation Practices (GDPs); comply with cGMPs, and company ISO standards
• Daily Supply list for respective area turned into receiving by scheduled time
• Comply with 503B guidelines; cGMPs, and company standards
• Perform equipment calibration checks and troubleshoot equipment as needed
• Complete documentation of activities in accordance with established procedures
• Immediate notification of production management of deviations to established processes or procedures
• Assist other areas as needed (cleaning; non-sterile filling; kitting and preparation operations, etc.)
• Primary, secondary and tertiary labeling of product
• Other duties as assigned
• Communication: Promotes active listening with team members; Contributes appropriately to conversations; Strong verbal and written communication skills with the ability to work effectively with other departments within the organization and with people at all levels of the organization
• Problem Solving: Understands how various issues affect each other and the outcome of projects; Improves upon existing approaches by seeking opportunities to creatively transform; mechanical aptitude a plus
• Interpersonal Skills: Effectively and productively engages with others and establishes trust, credibility, and confidence with others
• Customer Orientation: Listens to internal customers, ensures commitments are met, sets appropriate internal customer expectations
• Preferred working knowledge of cGMPs and regulatory requirements as well as all applicable SOPs
• Follows policies and procedures; completes administrative tasks correctly and on time
• Approaches others in a tactful manner; reacts well under pressure; treats others with respect and consideration regardless of their status or position; accepts responsibility for own actions; follows through on commitments
• Ability to sit and/or stand 8 hours or more per day if needed
• Ability to manipulate necessary office equipment, computer software, hardware & equipment
• Ability to perform the following physical activities: stooping, reaching, standing, grasping, walking, feeling, talking and hearing
• Ability to exert up to 50 pounds of force frequently or constantly to lift, carry, push, pull or otherwise move objects
• Ability to tolerate a work environment that uses cleaning chemicals in order to maintain a sterile manufacturing facility

Work environment is a registered 503B facility and requires compliance with many federal regulations including but not limited to the following:

• Required to wear neat and clean scrubs (preferably pocketless)
• Required to wear PPE
• Legs must be covered at all times
• You must wear flat shoes with closed-toes and closed-heels (no crocs)
• Nails should be kept short and well maintained, no nail polish (gel or acrylic)
• No personal electronic device usage in the production area
• No food/drink in the production area

Hours:

• You will be scheduled to work an 8-hour shift during the hours of operation
• Ability to come in prior to scheduled shift hours to support production needs
• Due to the nature of our work, working beyond the scheduled end of your shift is often necessary to complete a production batch and can be required with little or no notice
• Saturdays are expected to be worked when scheduled
• You may specifically be hired to work a later shift than we currently have available, if so, you will be assigned to work an existing shift as determined by your manager
• Training may not be scheduled during your normal shift, flexibility to work the hours necessary to complete training is required

Qualifications:

• Legally authorized to work in the job posting country
• High school Diploma or GED from recognized institution or organization required
• Minimum of 2 years reliable and sustained performance as a Production Technician II – ILP or pharmaceutical manufacturing experience
• Ability to work competently on all lines, including equipment: Equipment CA (PacMac, Labelers)
• Will be required to undergo a color perception exam and must be able to produce a passing test result
• Will be required to undergo a vision exam and must be able to produce 20/20 vision with or without correction

Candidates for regular U.S. positions must be a U.S. citizen or national, or an alien admitted as permanent resident, refugee, asylee or temporary resident under 8 U.S.C. 1160(a) or 1255(a)(1). Individuals with temporary visas such as E, F-1, H-1, H-2, L, B, J, or TN or who need sponsorship for work authorization now or in the future, are not eligible for hire.

It is the policy of Quva to afford equal opportunity for employment to all individuals regardless of race, color, age, national origin, physical or mental disability, history of disability, ancestry, citizenship status, political affiliation, religion, gender, transgender, gender identity, marital status, status as a parent, sexual orientation, veteran status, genetic information or other factors prohibited by law, and to prohibit harassment or retaliation based on any of these factors.

Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.For further information, please review the Know Your Rights notice from the Department of Labor.