Overview

Schedule: Three 12 hour shifts one week followed by four 12 hour shifts the next week.
And they alternate every other week. In a two week period contractor will work 84 hours.
Summary

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

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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 EBRs, 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 as required
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 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:

College degree or HS Diploma with +5 years industrial 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

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

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:

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

Job Types: Full-time, Contract
Salary: $26.50 per hour
Schedule:

8 hour shift
Day shift
Monday to Friday
Overnight shift

COVID-19 considerations:Candidate must be vaccinated
Ability to commute/relocate:

Malvern, PA 19355: Reliably commute or planning to relocate before starting work (Preferred)

Application Question(s):

manufacturing procedures, CGMP environment in the Manufacturing Core, Standard Operating Procedures Verifies and enters production parameters

Education:

High school or equivalent (Required)

Experience:

Production & Assembly Occupations: 5 years (Required)

Shift availability:

Day Shift (Preferred)

Work Location: One location