Scientific Process Operator
A Few Words About Us Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.
This is a contract position with my direct client.
Job Description
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
- Demonstrates 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
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
Qualifications
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
Mathematical Skills:
- Ability to apply concepts such as fractions, percentages, ratios and proportions to practical situations.
Other Skills, Abilities or Qualifications:
- Knowledge and ability to operate manufacturing equipment and hand tools
Physical Demands:
- 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 25 lbs