Quality Specialist I

On-Board Scientific is hiring a Quality Specialist I based out of West Point, PA!
Hybrid
For immediate consideration please send your resume to ******
Subject Line: Position Title and State you are located.

About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees.
We offer benefits as well as 401k. Position Details: Job Title: Quality Specialist I:
Position Type: 8-month+ contract with high possibility of extension for right candidate contingent upon performance and continued business need.

Job Location: West Point, PA
Shift: 1st shift
Compensation: $42.25 per hour
Please note: This is a hybrid role - 1-2 days a week remote - this option is only when the selected individual is fully trained.

Key skills: Batch record review experience Documentation experience SAP/LIMS/ electronic batch records (EBR)
The selected individual provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model.
With guidance from the IPT Quality Leadership team, the employee ensures product / process quality and performs activities to facilitate the release of product to the marketplace.
The candidate performs 100% process document review for accuracy and completeness and works closely with the assigned End to End (E2E) in a team environment to ensure timely review and documentation is done right first time.

Responsibilities: Performs 100% audit of process documents to ensure completeness and accuracy for assigned End to End (E2E).
Maintains any tracking databases and logs associated with this review.
Coordinates with Production to discuss, resolve, and eliminate documentation observations. Actively participates in the Tier process and uses this forum to escalate concerns and best practices. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans. Prioritizes review of process documents in order to maximize cycle-time efficiency. Performs SAP transactions required to document Batch Record review.
Qualifications: Minimum 1 year of relevant post-degree work experience in a laboratory, manufacturing, or quality position. Evidence of good oral and written communication skills, i.e.
effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills. Attention to detail, flexibility and an awareness of production and attendant quality control problems. Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Preferred Experience: Familiarity with vaccine and/or pharmaceutical processing. Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus. Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is beneficial. Familiarity with computer systems (SAP, LIMS, electronic batch records) is a plus.

Apply Today!

www.onboardusa.com

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry.
Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.


The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.
On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."


On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.

JD# 24-0On-Board Scientific is hiring a Quality Specialist I based out of West Point, PA!
Hybrid
For immediate consideration please send your resume to ******
Subject Line: Position Title and State you are located.

About Us: On-Board Services, Incorporated is an on-site contract service provider for a local manufacturing entity providing full time positions to our employees.
We offer benefits as well as 401k.
Position Details: Job Title: Quality Specialist I:
Position Type: 8-month+ contract with high possibility of extension for right candidate contingent upon performance and continued business need.

Job Location: West Point, PA
Shift: 1 st shift
Compensation: $37-42.25 per hour (based on experience)
Please note: This is a hybrid role - 1-2 days a week remote - this option is only when the selected individual is fully trained.


Key skills : Batch record review experience Documentation experience SAP/LIMS/ electronic batch records (EBR)
The selected individual provides direct Quality support to a production area as part of a Quality IPT (Integrated Production Team) operating model.
With guidance from the IPT Quality Leadership team, the employee ensures product / process quality and performs activities to facilitate the release of product to the marketplace.
The candidate performs 100% process document review for accuracy and completeness and works closely with the assigned End to End (E2E) in a team environment to ensure timely review and documentation is done right first time.


Responsibilities: Performs 100% audit of process documents to ensure completeness and accuracy for assigned End to End (E2E).
Maintains any tracking databases and logs associated with this review.
Coordinates with Production to discuss, resolve, and eliminate documentation observations. Actively participates in the Tier process and uses this forum to escalate concerns and best practices. Collaborates with IPT members in the identification and implementation of continuous improvement initiatives and action plans. Prioritizes review of process documents in order to maximize cycle-time efficiency. Performs SAP transactions required to document Batch Record review.
Qualifications: Minimum 1 year of relevant post-degree work experience in a laboratory, manufacturing, or quality position. Evidence of good oral and written communication skills, i.e.
effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills. Attention to detail, flexibility and an awareness of production and attendant quality control problems. Basic understanding of GMPs and of regulatory requirements as they apply to the pharmaceutical field or a related area.
Preferred Experience : Familiarity with vaccine and/or pharmaceutical processing. Familiarity with manufacturing batch records is a key skill necessary for success in this position; prior batch record experience is a strong plus. Experience in quality assurance audits or inspection of vaccine or pharmaceutical manufacturing areas is beneficial. Familiarity with computer systems (SAP, LIMS, electronic batch records) is a plus.

Apply Today!

www.onboardusa.com

On-Board was founded in 1976 by Robert L. Wilson to provide Engineering and Design services to the chemical manufacturing industry.
Today, On-Board is a thriving privately held family of companies with services including: Consulting, Professional Engineering, Industrial Maintenance and Facility Management, Contracted Manufacturing and Production Services, as well as Temporary Staffing and Recruiting throughout North America.


The On-Board Family of Companies conducts operations through its Corporate Headquarters located in East Windsor, NJ along with Regional Offices in New Castle, DE and Wake Forest, NC.
On-Board's Mission is to provide "Flexible Service by applying the talents of our people, work processes and technology to meet our clients' expectations in a Safe, Responsible and Dependable manner."


On-Board Companies provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, religion, sex, national origin, age, disability or genetics.


JD# 24-02366 Tag: INDOJ Tag: INDOJ