Pharmaceutical Packaging Technician II -3rd Shift

We have an opportunity for a CSS Pharmaceutical Packaging Technician II -3rd Shift to join our team supporting clinical trial projects through the packaging of clinical trial supplies. The role ensures all work is carried out in compliance with regulatory requirements, good manufacturing practices, and standard operating procedures. This position reports to the Production Supervisor and may receive tasks from Room Leads and Team Leads. The ideal candidate will maintain high standards of safety, quality, and compliance while contributing to the success of clinical packaging operations.

Shift: Sunday-Thursday 10:30pm-7am Location: Kansas City, MO 100% Onsite

The Role

• Ensure that during all packaging operations the site's safety, quality, and compliance metrics are met or surpassed while meeting corporate and site standards and policies.
• Execute clinical and commercial batch records in both primary and secondary packaging areas.
• Demonstrate a patient-first customer focus mindset.
• Alert management of any potential deviations or infractions in a timely manner.
• Maintain and stay current on all necessary training required to support both primary and secondary packaging operations in Compliance Wire and all other GMP and work-related classroom training.
• Develop skills necessary to work with and clean all semi-automated and automated pieces of equipment.
• Accurately review packaging batch records prior to packaging process to ensure processing instructions are followed in accordance with standard operating procedures.
• Prepare, complete, and correct documentation following good documentation practices and in compliance with standard operating procedures and good manufacturing practices.
• Inspect drug products, components, and clinical labels for defects, blemishes, or missing text prior to and during production.
• Apply labels consistently following all visual and written procedures.
• Clear a Drug Enforcement Agency background check for handling controlled and special security drug substances.
• Understand and comply with gowning and de-gowning requirements for each production area (primary, secondary, and potent packaging suites).
• Strictly adhere to hygiene and gowning procedures.
• Mix and handle cleaning detergents for cleaning processing areas and packaging equipment.
• Maintain a high level of cleanliness in the workspace.
• Clean associated packaging equipment and packaging rooms in compliance with standard operating procedures.
• Follow all site safety, human resource, and security policies.
• Be punctual for work, meetings, and breaks.
• Perform all other duties as assigned.

• High School degree or equivalent.
• Demonstrated ability to read, write, and speak English effectively.
• Proven written and verbal communication skills.
• Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
• Ability to work in a team environment.
• High attention to detail.
• Above average organizational skills in alignment with 5S standards.
• Ability to work effectively under pressure to meet competing workplace demands while maintaining the highest level of quality in all work performed.
• Basic computer skills, including e-mail, Microsoft Word, and Internet Explorer.
• Basic mathematical skills.
• 20/30 corrected vision exam required.
• Respirator fit testing and pulmonary physical required.
• Handling of controlled substance product requires a Drug Enforcement Agency background screening.
• Work in a highly active containment area (Potent Drug Facility).
• Operate a manual pallet jack and may become licensed to operate the pallet stacker as needed.
• Must be available to work occasional overtime.

• Clinical trial packaging or related manufacturing/operations experience preferred.

• Defined career path and annual performance review and feedback process.
• Diverse, inclusive culture.
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives.
• Competitive paid time off plus 8 paid holidays.
• Community engagement and green initiatives.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.