The Packing Operator is responsible for producing packaged pharmaceutical products in a safe and efficient manner, complying with cGMP’s, SOPs, and site safety procedures.
We have several shift positions available.

Responsibilities:
o Operate packing equipment (tablet fillers, thermoforms, labelers, case packers, etc.) in a safe and efficient manner.
o Must understand and comply with cGMP’s, SOPs and site safety procedures.
o Verify correctness of product and components for the NDC packaged.
o Supply equipment with components and product. Lifting requirements may be up to 50 lbs.
o Perform detection system challenges on applicable equipment.
o Perform basic maintenance, changeover, set up, and troubleshooting of packaging equipment.
o Clean, purge, and inspect packaging equipment.
o Accountable for accurately documenting, packing, and cleaning activities in logbooks and electronic systems.
o Perform quality attribute inspections and in-process testing (torques, induction seal integrity, leak tests, appearance, etc.)
o Rework packages according to SOPs or Rework Packaging Order to correct deviations.
o Attend regular SHE and GMP meetings.
o Share knowledge with co-workers for training purposes.
o Work effectively in teams to meet monthly demand requirements.
o Identify areas for continuous improvement and efficiency improvements, and implement fixes for these ideas.
o Accountable for Line performance (OEE) and able to report hourly status of line to affected personnel to ensure timely resolution to issues. (i.e. Facilitators, Engineers).
o Must be able to work off shifts, weekends, alternative schedules, and rotate between shifts when production demands require.
o Must be flexible to change.
o Ability to perform duties with minimum supervision.
o Conduct activities and interactions consistent with Company values and in compliance with the Code of Ethics and supporting Policies and Standards relevant to your role.
o Complete all required training on the company's Code of Ethics and supporting Policies and Standards on time. Report potential issues of non-compliance.
o Ensures compliance with company's Corporate Policies and Directives, site Standard Operating Procedures, site policies, work instructions, regulatory requirements, and industry best practice (cGMPs, GAMP, ITIL, PMI).
o Maintains a safe work environment and performs work in accordance with site, Safety, Health, and Environment (SHE) policies and procedures.
o Immediately report potential unsafe conditions to management.
o Supports internal, external, and regulatory inspections including FDA, EMEA, and third-party inspections.
o Participates in the investigation and resolution of product quality problems.

Qualifications:
Education:
o High School Diploma / GED required

Required:
o Excellent verbal, written, and interpersonal communication skills.
o Basic mechanical aptitude.
o Basic computer skills.

Preferred:
o Minimum of one (1) year experience in production environment, preferably pharmaceuticals.
o Experience in pharmaceutical production environment.
o Knowledge of cGMPs.

Note: This job description is intended to provide a general overview of the position. It is not an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the role.