Quality Consulting Group, LLC
JT878 - MANUFACTURING PROCESS TECHNICIAN - NS
Quality Consulting Group, LLC, New Albany, Ohio, United States, 43054
QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.
Responsibilities
Performs manufacturing processes according to Standard Operating Procedures.
Operating high speed packaging equipment
Must be proficient at Associate Manufacturing and may perform those functions in addition.
Perform initial review of manufacturing procedures/batch records.
Draft and revise more complex documents (e.g. MPs, SOPs, technical reports, validation documents, investigation reports, etc.)
Audit critical records.
Propose
corrective action
for Quality incidents.
Assist& plan improvement implementation related to routine functions.
Interact with other departments to implement planned improvements.
Identify and propose solutions to complex problems.
Perform data analysis (e.g., SPC, CPV) of critical process parameters.
Lead capacity for equipment/process operations.
May perform system owner responsibilities (i.e., process, document).
Supports manufacturing procedures (and other related documentation) generation and review process.
Troubleshoots process and assesses process performance thru process monitoring.
Supports NC CAPA process by completing process assessments and participating in cross functional investigational teams,
defining and implementing CAPAs and reporting incident trending.
Assists in the generation, review and execution of process validation protocols.
Supports
new product introduction and product life cycle.
Initiates and Implement
Level 1 and Level 2 Change Control
records.
Qualifications
Bachelor’s degree in
Life Science and/or Engineering
1-3 year of experience
in manufacturing preferably in a FDA regulated environment.
Mechanical ability/expertise.
Understand equipment/processes.
Technical writing capability.
Ability to
interpret and apply GMP concepts.
Understand
analytical methods
for manufacturing area.
Basic
project management
skills.
Shift:
3rd shift from 3:30pm - 2:00 AM (Mon – Thu)
Some Fridays are
worked and overtime .
Can expect to need to work
OT 2x/month
on average
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
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Responsibilities
Performs manufacturing processes according to Standard Operating Procedures.
Operating high speed packaging equipment
Must be proficient at Associate Manufacturing and may perform those functions in addition.
Perform initial review of manufacturing procedures/batch records.
Draft and revise more complex documents (e.g. MPs, SOPs, technical reports, validation documents, investigation reports, etc.)
Audit critical records.
Propose
corrective action
for Quality incidents.
Assist& plan improvement implementation related to routine functions.
Interact with other departments to implement planned improvements.
Identify and propose solutions to complex problems.
Perform data analysis (e.g., SPC, CPV) of critical process parameters.
Lead capacity for equipment/process operations.
May perform system owner responsibilities (i.e., process, document).
Supports manufacturing procedures (and other related documentation) generation and review process.
Troubleshoots process and assesses process performance thru process monitoring.
Supports NC CAPA process by completing process assessments and participating in cross functional investigational teams,
defining and implementing CAPAs and reporting incident trending.
Assists in the generation, review and execution of process validation protocols.
Supports
new product introduction and product life cycle.
Initiates and Implement
Level 1 and Level 2 Change Control
records.
Qualifications
Bachelor’s degree in
Life Science and/or Engineering
1-3 year of experience
in manufacturing preferably in a FDA regulated environment.
Mechanical ability/expertise.
Understand equipment/processes.
Technical writing capability.
Ability to
interpret and apply GMP concepts.
Understand
analytical methods
for manufacturing area.
Basic
project management
skills.
Shift:
3rd shift from 3:30pm - 2:00 AM (Mon – Thu)
Some Fridays are
worked and overtime .
Can expect to need to work
OT 2x/month
on average
Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
#J-18808-Ljbffr