Malvern, PA - Scientific Process Operator

JOB DESCRIPTION

• This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment in the Formulations Manufacturing Cell
• This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations

ESSENTIAL FUNCTIONS:

• Executes manufacturing processes according to standard operating procedures
• Verifies and enters production parameters per SOP and Batch Record on trained procedures
• Retrieves and analyze trend charts and process data on trained procedures
• Accurately completes documentation in SOP's, logbooks and other GMP documents
• Demonstrate training progression through assigned curriculum
• Accountable for adherence to compliance policies and regulations
• Wear the appropriate PPE when working in manufacturing and other hazardous working environments
• Takes necessary action to eliminate safety hazards and communicate to others any observed unsafe behaviors

ADDITIONAL RESPONSIBILITIES/DUTIES:

• Carries out duties in compliance with all state and federal regulations and guidelines including FDA, EPA and OSHA
• Adheres to the Safety Code of Conduct & EHS policies and attend all required EHS training

Support the ongoing production schedule by:

• Report to work on-time and according to the shift schedule
• Be available for other duties as assigned
• Attend departmental and other scheduled meetings
• Good interpersonal and communication skills
• Demonstrates positive team-oriented attitude in the daily execution of procedures
• Promote and work within a team environment
• Continue professional development through learning new skills, procedures, processes and seminars

*This is not an exhaustive or comprehensive listing of job functions.  May perform other duties as assigned.

Qualifications:

Autonomy and Complexity

• Basic Technical Knowledge within functional area
• Introduced to troubleshooting of routine manufacturing processes
• Needs direction to perform daily tasks
• May offer suggestions for process improvements
• Basic GMP understanding
• Attend PE awareness classes and may participate PE projects

EDUCATION and/or EXPERIENCE:

• 0-2 Years Biotech/Pharmaceutical experience or equivalent industry experience
• HS Diploma required

COMPUTER ABILITY:

• Basic Understanding of MS Office, Windows and XP

LANGUAGE SKILLS:

• Read and interpret documents such as safety rules, operating instructions and logbooks
• Review and provide feedback for SOP and Batch Record revisions

REASONING ABILITY:

• Interpret a variety of instructions furnished in written, oral, diagram, or schedule form
• Follows instructions
• Solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
• Work with high level of concentration
• Accept and adapt to procedural changes

MATHEMATICAL SKILLS:

• Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals

OTHER SKILLS, ABILITIES OR QUALIFICATIONS:

• Knowledge and ability to operate manufacturing equipment and hand tools

PHYSICAL DEMANDS:

• While performing the duties of this job, the employee:
• Needs to be mobile and able to independently transport themselves between various sites/locations, as dictated by the essential functions and responsibilities of the position.
• Is frequently required to talk or hear.
• While performing the duties of this job, the employee is regularly required to stand; walk; use hands to finger, handle, or feel; climb, bend and stoop; and reach with hands and arms
• Ability to lift 20 lbs

SUBMIT RESUME to Resume@ABOUT-Consulting.com
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