Manufacturing Associate I - 1st Shift

Endo•Hobart, NY

5d•Onsite

About The Position

Processes active compound materials into final tablet form and performs quality control checks to maintain product consistency according to manufacturing specifications. Executes production processes while adhering to cGMP, Standard Operating Procedures, documentation protocols, environmental health and safety guidelines, and other applicable regulations. Participates in departmental projects and relevant quality working teams, supports the leader and subject matter experts, and contributes to production, operations projects, and process improvements. Maintains accurate and compliant documentation. The role involves obtaining, weighing, and moving materials; operating pharmaceutical manufacturing equipment; performing quality checks and submitting samples; maintaining batch, room, and equipment records; monitoring production and making operator-level adjustments; and assisting with equipment setup, troubleshooting, cleaning, and minor repairs. The associate follows safety, security, hazardous-waste, and escalation procedures and helps maintain clean work areas. May assist at other stations and may be cross-trained in other functions. The position is at the Hobart, New York facility and works Monday through Thursday, 6:00 a.m. to 4:15 p.m. The associate must be able to work overtime when needed. The expected base pay is $24.03 per hour, and the position is eligible for a discretionary bonus under the applicable program. Visa sponsorship is not available; applicants must be authorized to work in the United States without current or future sponsorship needs.

Requirements

High school diploma or GED.
Basic knowledge and ability to apply mathematical concepts, spelling, English reading, and grammar.
Ability to work overtime when needed.
Applicants must be authorized to work in the United States without current or future visa sponsorship.
Ability to meet the physical, visual, and environmental demands of the role, including frequent handling and moving of materials and regular use of protective equipment.

Nice To Haves

Three to twelve months of experience under direct supervision and guidance is recommended to gain sufficient skill to perform the position requirements.
May be cross-trained in other functions.

Responsibilities

Obtain and weigh products for all shifts and move raw materials and product to and from vault, cage, process, or storage areas.
Inspect machine parts for unusual wear and proper lubrication and operate equipment used to manufacture pharmaceutical products.
Perform or review tablet quality checks, including weight, thickness, hardness, and friability, according to manufacturing instructions and SOPs.
Submit product samples to quality laboratories as required.
Maintain product batch, room activity, equipment, inspection, cleanup, and other required records.
Maintain control of DEA-scheduled material in accordance with applicable policies and procedures.
Be at the assigned position ready to start production as required; monitor the production process and make periodic checks and adjustments to support production efficiency, yields, quality, and safety.
Accurately report production and complete required reports.
Perform operator-level machine adjustments and lubrication; assist technicians with minor repairs and setup; troubleshoot equipment and processing issues to minimize production disruptions.
Prepare for product changeovers by ensuring materials, paperwork, and equipment are staged and line conditions are acceptable.
Immediately stop manufacturing and notify the Line Leader of safety or quality concerns.
Disassemble, clean, inspect, and reassemble basic line equipment according to SOPs; clean and assemble dust collectors.
Assist in training individuals on departmental equipment and processes.
Follow EHS rules, site security requirements, safe working practices, and lock-out/tag-out procedures; identify unsafe conditions and participate in site and departmental safety initiatives.
Collect process-related hazardous waste and transport it to accumulation drums.
Maintain a clean work area and clear debris, damaged or defective product, cartons, labels, and packaging supplies.
Attempt to identify root causes within decision-making authority while notifying the next level of leadership, and escalate unresolved problems as appropriate.
Assist technicians at other stations as needed, work at trained tableting stations, and potentially cross-train in other functions.