Please note that this is a 6 month contract position.
**************This is 3rd shift 10:00PM to 6:30AM**************
This position is responsible for performing manufacturing procedures and the execution of scheduled tasks within a CGMP environment. This position is responsible for quality and maintaining the highest standards in compliance within company policies, procedures and all applicable regulations.
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
- 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 & Client policies and attend all required EHS training
- Follows Global Leadership Profile (GLP) competencies based on their leadership level within the organization (Individual Leader)
- 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
ESSENTIAL FUNCTIONS PER JOB LEVEL:
- This is not an exhaustive or comprehensive listing of job functions. May perform other duties as assigned.
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:
1-2 Years Biotech/Pharmaceutical experience or equivalent industry experience
HS Diploma required
Basic Understanding of MS Office, Windows and XP.
Read and interpret documents such as safety rules, operating instructions and logbooks
Review and provide feedback for SOP and Batch Record revisions.
- 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
OTHER SKILLS, ABILITIES OR QUALIFICATIONS:
- Add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.
Knowledge and ability to operate manufacturing equipment and hand tools
Use of Process Excellence Tools
While performing the duties of this job, the employee:
For consideration please include Dice # 6897
- 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
Dice - 3 years ago