Pharmaceutical Company.

POSITION SUMMARY: 

This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment in the Operations Services group. 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 Technical Operations and Operational Services 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 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. 

ESSENTIAL FUNCTIONS PER JOB LEVEL: 

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 

 Good understanding of cGMP 

 Attend PE awareness classes and may participate PE projects 

COMPUTER ABILITY: 

 Computer literate 

 Working knowledge of MS Office, MS Word, MS Excel, Windows or equivalent is required 

 Ability to learn and operate a range of industry systems including SAP Production, Werum MES, Compliance-Kaplan Wire and others 

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 both verbal and written instructions (100% adherence to SOPs) 

 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 

EDUCATION and/or EXPERIENCE: 

 College degree or HS Diploma with +5 years biopharmaceutical industry experience 

 Experience must be Biotech/Pharmaceutical industry or relevant experience working with Standard Operating Procedures (SOP's) where formal documentation is required 

 Previous experience with MES would be an advantage 

 Knowledge of routine and non-routine testing and sampling methods, techniques and related equipment would be an advantage 

College degree or HS Diploma with +5 years biopharmaceutical industry experience