Drug Product Manufacturing Associate I - 1st Shift

Essential Duties and Responsibilities

• Train in one or more areas of the aseptic manufacturing of injectable pharmaceuticals using GMPs in an FDA regulated facility.
• Complete required SOP training and execute training curriculum.
• Prepare materials needed for aseptic operations.
• Exhibit professional behavior with both internal and external business associates that reflects positively on the company and aligns with company’s policies and practices.
• Perform various routine manufacturing tasks on complex equipment in accordance with established SOPs and cGMP regulations.
• Accurately document data and complete batch records as required.
• Reliably execute well defined SOPs.
• Operate in clean room environments in accordance with established policies and procedures.
• Collect and dispose of lab waste according to established procedures.
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
• Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
• Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture.
• Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures

Special Demands

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• occasionally required to sit, and to reach to use computers and other office equipment
• constantly stand for extended periods of time, up to four (4) hours/time.
• frequently required to lift up to 50 pounds
• constantly required to view objects at close and distant ranges with hand and eye coordination
• frequently required to communicate with others
• constantly performs duties while donning aseptic gowning.

Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the workday, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Qualifications

• High school diploma required; bachelor’s degree in a science or engineering discipline preferred.
• Minimum of zero to two (0-2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions.
• Ability to follow instructions under direct supervision.
• Detail oriented with strong written and verbal communication skills.
• Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
• Familiarity with cGMP, manufacturing processes, machine operation, and data entry.
• Must be familiar with Microsoft Office applications.