Pharmaceutical Packaging Technician II - 3rd Shift

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.

The Candidate

Minimum Requirements

• 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.

Preferred Skills & Background

Clinical trial packaging or related manufacturing/operations experience preferred.