GMP Packaging Specialist

Job Description

Job Description

Job Title: Pharmaceutical Packaging Specialist

Shift: 1st Shift – 6:30am-3pm

Pay: $19/hr

Location: Kansas City, MO

 

Summary:

 

This is an entry-level position created to support clinical trial projects through the packaging of clinical trial supplies. All activities performed will ensure that all work is carried out in compliance with regulatory requirements, good documentation practices (GDP), current good manufacturing practices (cGMP) and standard operating procedures (SOPs). This position reports to the Production Supervisor and may accept tasks issued from Room Leads and Team Leads.

 

Essential Functions:

• 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
• Establish a strong working knowledge of cGMP, GDP, local site policies and regulatory requirements
• Develop proficiency in packaging batch record execution in accordance with SOPs and regulatory requirements by ensuring that all entries into the batch record will be right the first time
• Develop a Patient first customer focus mindset
• Establish an understanding of clinical trials and how they relate back to the work performed in clinical packaging
• Complete training and execute documentation in compliance with SOPs and GDP
• Inspect drug product, components, and clinical labels for defects, blemishes or missing text prior to and during production
• Develop a high aptitude for cleanliness in the work space
• Label application to consistently follow all visual/written procedures
• Clean associated packaging equipment and packaging room(s) in compliance with SOPs

 

Requirements:

 

• High School degree or equivalent.

• Proven written and verbal communication skills
• Ability to work in a team environment
• High attention to detail
• Basic computer skills – including, but not limited to e-mail, Microsoft Word, Internet Explorer
• Basic mathematical skill

 

Physical Requirements:

• Must pass vision exam with 20/30 corrected vision for distance and 14/20 for near sighted
• Able to distinguish all colors
• May be required to operate a manual pallet jack
• Position requires ability to spend extended periods of time in the following GMP environments:
• Controlled Room Temperature 68 degrees F – 77 degrees F (15 degrees C – 25 degrees C)
• Refrigerator 35 degrees F – 46 degrees F (2 degrees C – 8 degrees C)

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