On-Board Scientific is hiring a QA Specialist in Devens, MA!

For immediate consideration please send your resume to resumes@onboardusa.com
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:
Title: QA Specialist
Position Type: Full Time / 6-month contract
Shift: 8:00am-5:00pm
Job Location: Devens, MA
Benefits: 401K, Medical, Dental, Vision, and Life Insurance
Compensation: $36.60 hourly

Summary:
The Quality Specialist will focus on Quality review and approval of supplier documents to support qualification of GMP starting materials for biologics (large molecules) drug substances. The scope of documents will range from TSE/BSE statements through Quality release of supplier products. Specific technical document types include stability/ lifecycle of materials, test method comparisons and risk assessments. This Quality role will also partner with Procurement teams to source, resolve associated deviations and other exceptional conditions, and assist with CAPA identification and resolution.

Duties & Responsibilities:

• Assist with the lifecycle management of material qualifications, including reduced testing and direct dispense.
• Assist with quality review of risk assessments associated with material qualification.
• Performs quality assessment of Supplier Change Notifications for impact to site.
• Assists in discrepancy reporting, deviations and CAPAs associated with nonconforming/defect material.
• Performs quality review for area documents including SOPs, Technical Documents/Reports and Forms.
• Assist in resolution of supplier/material related issues as they arise.
• Assist team on cross-site improvement initiates.

Qualifications:

• Knowledge of science generally attained through studies resulting in a B.S., in science, engineering, biochemistry, related discipline, or its equivalent.
• A minimum of 4 years with directly relevant experience in a regulated environment is required.
• Knowledge of regulated activities such as Good Documentation Practices (GDP) and Standard Operating Procedures (SOPs).
• Demonstrate proficiency in common computer tools such as word processing, spreadsheet and web based applications.
• Past experience where one was required to work in a team based environment with a diverse group of people.
• Previous work experience where attention to detail and personal accountability were critical to success.
• Strong communication skills and the ability to follow written and verbal instructions.
• Specific experience with processing of biological samples for downstream characterization is preferred.
• Experience with designing, optimizing, and running high-throughput assays is preferred.
• Proficiency in utilizing software such as Graph Pad, Microsoft office etc. for data analysis and figure generation is required.
• Excellent organizational skills and ability to maintain good records of laboratory data.

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# 23-01522