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:
Position Type: Senior Specialist Quality Assurance
Job Location: Durham, NC
Compensation: $58.49 per hour
Length of Assignment: 1 year with a possibility of extension
1st shift hours
*Note*: This is onsite role at Durham, NC for 1 year with possibility of extension.

Overview:
Our client’s Quality Assurance group ensures all materials inside our products and the products themselves are manufactured, tested, and distributed in alignment with our high standards of quality.
Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers, we create an interdependent global manufacturing network committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
Our client will construct a new manufacturing facility to significantly expand its production capacity for a medicine for the treatment of certain forms of bladder cancer.
Global demand has outpaced our client’s current maximum manufacturing capabilities.
Once this new facility is fully operational, our client will triple our current manufacturing capacity, which is expected to support the anticipated demand for the foreseeable future.
This investment reaffirms our clients longstanding commitment to producing this medicine for the patients who need it. The facility will include end-to-end processing of drug substance, drug product, including biotech culture growth, harvest, lyophilization, product inspection, and quality control laboratories.

Requirements:
The Quality Assurance Senior Specialist will support this expansion. Project activities requiring support include the capital project to construct the facility, process and technology introduction, compliance improvements, and manufacturing readiness to initiate production of commercial product.

• The focus for the position includes all aspects of Quality oversight for drug product, drug substance, media preparation, and sterile supply.
• Reporting to the Quality Assurance Organization, will independently manage project assignments.
• Ensure all aspects of the project proceed in compliance with cGMP, regulations, and our Company’s Quality Management System.
• Focusing on areas such as Commissioning, Qualification and Compliance covering Manufacturing Equipment (isolator, restricted access barrier, incubator, washer, autoclave, formulation vessel, lyophilizer, etc.).
• Provide QA support including critical / constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ and other technical documents to meet schedule milestones.
• Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, technical reports.
• Partner with site and above site functions to solve problems and achieve goals.
• Makes decisions guided by policies and procedures that impact the team’s ability to meet performance objectives.
• Consults on an as-needed basis with next level manager on more complex decisions.

Qualifications:

• Bachelor's and/or Master’s Degree in chemical engineering, biochemical engineering, biological systems engineering, biology, biochemistry, chemistry or related life science or engineering discipline.

• Will consider Associate degree if they have 7+years of relevant experience.
• With Bachelor’s Degree, at least 5 years of experience in the pharmaceutical industry or highly regulated industry.
• With Master’s degree, at least 3 years of experience in the pharmaceutical industry or highly regulated industry.
• Experience with review and approval of URS, FAT, IQ, OQ, PQ for manufacturing equipment, facilities and utilities.
• Strong contemporary knowledge of relevant current good manufacturing practices (cGMPs), regulations and current industry trends.
• Effective decision making, problem solving and communication skills. Ability to manage multiple priorities.
• Demonstrated ability to work in fast-paced, complex environments and escalate appropriately.

Preferred Experience and Skills :

• GMP quality experience with biological drug substance or drug product.
• GMP experience with qualification of equipment.
• Experience with Quality Risk Management.
• Project Management experience in a highly regulated industry.
• Experience with Kneat, SAP, Trackwise and/or GLIMS

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.

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