What are the responsibilities and job description for the Senior Specialist Quality Assurance - Level III (Senior) position at On-Board Companies?
On-Board Services is hiring a Senior Specialist Quality Assurance – Level III based out of Durham, NC!
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are Located
Position Details:
Position Type: Senior Specialist Quality Assurance – Level III
Job Location: Durham, NC
Compensation: $58.50 per hour
Length of Assignment: 1 year with a possibility of extension
** Please be advised that the individual selected for this role would need to complete BCG Medical Surveillance prior to the start of work.
Responsibilities:
Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
• Reporting to the Quality Assurance Organization, will independently manage project assignments.
• Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.
• Immediate project support on review and approval of commissioning and qualification (C&Q) documents to support project delivery.
• Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, other technical documents, change management, and manufacturing/batch documents to meet schedule milestones.
• Ensure all aspects of the project proceed in compliance with cGMP, regulations, and our Company’s Quality Management System.
• Focusing on areas such as Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).
• Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports.
• Consults on an as-needed basis with next level manager on more complex decisions.
Qualifications:
• Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years’ experience in the Pharmaceutical Industry.
• Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.
• Must have 3 years of experience with development, review, and approval of User Requirement (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities and utilities.
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# 25-03532
Tag: INDOJ
For immediate consideration please send your resume to resumes@onboardusa.com
Subject Line: Position Title and State you are Located
Position Details:
Position Type: Senior Specialist Quality Assurance – Level III
Job Location: Durham, NC
Compensation: $58.50 per hour
Length of Assignment: 1 year with a possibility of extension
** Please be advised that the individual selected for this role would need to complete BCG Medical Surveillance prior to the start of work.
Responsibilities:
Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products.
• Reporting to the Quality Assurance Organization, will independently manage project assignments.
• Must have strong demonstrated interpersonal, communication, negotiation, and persuasion skills. Must have very strong relationship building skills.
• Immediate project support on review and approval of commissioning and qualification (C&Q) documents to support project delivery.
• Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, other technical documents, change management, and manufacturing/batch documents to meet schedule milestones.
• Ensure all aspects of the project proceed in compliance with cGMP, regulations, and our Company’s Quality Management System.
• Focusing on areas such as Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).
• Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports.
• Consults on an as-needed basis with next level manager on more complex decisions.
Qualifications:
• Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years’ experience in the Pharmaceutical Industry.
• Must have working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products with experience in quality assurance oversight of sterile manufacturing, sterile process validation and/or sterile process technology transfer.
• Must have 3 years of experience with development, review, and approval of User Requirement (URS), FAT, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities and utilities.
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# 25-03532
Tag: INDOJ
Salary : $59
