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PharmaLex is a highly successful and growing consulting company for the Healthcare industry around the world.
PharmaLex offers professional development, plus a stimulating and collaborative work environment.
We are committed to providing exciting career opportunities in an atmosphere that values trust, respect, teamwork, creative talent, enthusiasm, and diligence.
Job Description With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions.
Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems.
FUNCTIONS Applied Process Expertise 1.
Initiate, revise, and approve manufacturing procedures.
Ensure all procedures reflect current operations.
Serve as a document owner.
2.
Assess process performance by observation of floor operations and review of performance data.
Evaluate, plan, and implement solutions for process improvement opportunities.
3.
Provide troubleshooting support.
4.
Assist in generation of training materials and may assist in providing training on scientific or technical aspects of the process.
Process Monitoring 1.
Support establishment of process monitoring parameters and control limits.
Collect process-monitoring data and support the assessment of deviations.
2.
Provide support of timely execution of the process monitoring quarterly reports.
Non-Conformance and CAPA 1.
Ensure that all Non-conformances are triaged within the established goal.
2.
Responsible for authoring investigation reports.
3.
Responsible for execution of corrective actions.
4.
Responsible for managing NC/CAPA closure within established goal.
5.
Monitor and communicate incidents trends.
6. Review equipment/system Root Cause Analysis investigations and support trend evaluations.
Process Validation 1.
Assist with generation of process validation protocols and reports.
2.
Assist with the execution of the process validation.
3.
Support collection and analysis of process validation data.
Regulatory 1.
May participate in regulatory inspections New Product Introductions & Process or Equipment Modifications 1.
Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications.
2.
Assess, prioritize, justify, and provide implementation and project management support for process or equipment modification projects.
Change Control 1.
Assist manufacturing change owner on CCRB packages impacting the process.
Projects and Initiatives 1.
Participate on the assessment or implementation of special projects or initiatives.
Preferred Qualifications: Experience managing facilities change control.
Decommissioning processes experience.
Experience using Trackwiise and Veeva.
Doctorate degree OR Master's degree and 3 years of Operations experience OR Bachelor's degree and 5 years of Operations experience or Associate degree and 10 years of Operations experience or High school diploma / GED and 12 years of Operations experience.
Any Engineering, typically Industrial Engineering is more suited for this role.
Shift: 8am - 5pm PharmaLex is an Equal Opportunity Employer.
We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, creed, national origin, ancestry, sex, age, handicap or disability, marital status, sexual orientation, gender identity or expression, pregnancy or pregnancy-related condition, genetic information, veteran status, immigration or citizenship status, military obligations, status as a domestic violence victim or a victim of sexual assault or stalking, participation in discrimination complaint-related activities, or any other status protected under applicable federal, state or local law.
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