Job Overview:
As a Pharmaceutical Packaging Technician, you will be responsible for packaging a range of pharmaceutical products for clinical and commercial use. You will operate, set up, maintain, and clean equipment while following established standardized procedures. Additionally, you will thoroughly document production efforts to ensure compliance with regulatory ... guidelines.
Responsibilities:
• Performs assigned duties as outlined in the SOPs for packaging of pharmaceutical products according to written instructions from Packaging Labeling records with assistance from a trained packaging technician.
• Under the guidance of a junior or senior packaging technician, assists in the setup, operation, disassembly, and monitoring of packaging equipment per specifications or packaging instructions for solid, semi-solid, and liquid dosage forms.
• Assists in performing cleaning procedures on packaging equipment and areas using written procedures, cleaning solutions, and materials under the guidance of a trained packaging technician.
• Notifies Management of any observed cGMP violations encountered during the performance of job duties and responsibilities.
• Follows all safety procedures within the cGMP packaging areas and reports all discrepancies to management immediately.
• Ensures the work area is neat, clean, and orderly by end of the shift.
• Enhance organizational reputation by striving to meet and exceed performance expectations.
• Work cooperatively with Quality Assurance and other internal departments to ensure appropriate coordination of manufacturing activities.
• Maintain job knowledge and training current to ensure compliance in all activities.
• To identify, investigate, participate in, and take ownership of compliance issues and deviations when discovered.
• Support the identification and implementation of corrective and preventive actions (CAPAs).
• Perform other duties as assigned.
Qualifications:
• HS/ GED required with a minimum of 18 months experience as a Junior Packaging Technician within Pii or a minimum of 3 years in the pharmaceutical, cosmetic, or food industry, or equivalent combination of education, training and professional experience that provides the individual with the required knowledge, skills, and abilities.
• Ability to add, subtract, multiply and divide all in units of measure, using whole numbers, common fractions and decimals, and percentages.
• Must have the ability to learn the metric system, weight, and volume measurements.
• Mechanically inclined; reads and interprets equipment and process documents; follows operating instructions.
• Exhibits objectivity and openness to others’ views. Takes personal accountability for contributions to the team and organizational results.
• Demonstrated accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality.
• Demonstrate the ability to establish good working relationships with other departments, including vendors, colleagues, and subordinates.
• Demonstrates the appropriate technical knowledge necessary to make sound decisions on development issues with minimal supervision.
• Demonstrate the ability to analyze data and information and assess and resolve complex problems/issues as required.
• Must be able to comprehend and follow all applicable SOPs.
• Demonstrate knowledge and experience with electronic Quality Management Systems such as MasterControl and Trackwise.
• Demonstrate ability to acquire the appropriate knowledge from resources on the current federal, local, and international regulations regarding the production, testing, and release of drug substances and products.
• Good understanding of cGMPs, industry, and regulatory standards and guidelines.
• Demonstrate familiarity with Microsoft programs like Word, Excel, PowerPoint, Project, Teams, Outlook, etc.
• Demonstrate the ability to portray the appropriate level of integrity and professionalism.
• Demonstrate the ability to communicate effectively with management, staff, regulators, and client representatives in written and verbal formats.
• Demonstrate the ability to complete tasks accurately and according to established and shifting timelines.
• Demonstrate the ability to make quality scheduling, resource allocation, and priorities decisions.
• Energetic, execution-focused, self-motivated, and organized individual who is accustomed to working in a deadline-focused, high-pressure entrepreneurial environment.
• Results-oriented and efficient.
• Creative and open-minded who fosters an environment in which sharing of ideas is encouraged.
• Demonstrate the ability to work closely with a diverse customer and employee base (internally and externally).
• Demonstrate the ability to work well in a cross-functional team environment.
• Must communicate fluently in English and have legible handwriting.
Physical Demands:
• Ability to travel between and within facilities to visit staff, operations, and projects, as needed.
• Ability to sit, stand, climb stairs, and climb ladders to mezzanines (when necessary).
• Ability to lift up to 40 pounds on occasion.
• Ability to use PPE (safety shoes, goggles, respirators, gloves, etc. when necessary
