QA Contractor, GMP Quality Assurance

TalentBurst, Inc.

RTP, NC

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JOB DETAILS

SALARY

$38.07–$38.07 Per Hour

SKILLS

Analytical Method Validation, Biotech and Pharmaceutical, Cell Cultures, Change Control, Communication Skills, Continuous Improvement, Contract Manufacturing, Corporate Compliance, Corrective and Preventative Action (CAPA) Systems, Customer Relations, Detail Oriented, Document Archiving, Document Management, FDA Requirements, GMP (Good Manufacturing Practices), Gene Therapy, Health Maintenance, Internal Audit, Laboratory, Learning Management System (LMS), Metrics, Microsoft Excel, Microsoft Office, Microsoft PowerPoint, Microsoft Word, Multitasking, Organizational Skills, Performance Metrics, Presentation/Verbal Skills, Problem Solving Skills, Procedure Development, Quality Assurance, Quality Control, Quality Management, Realtime Transport Protocol, Regulations, Regulatory Compliance, Regulatory Requirements, Standard Operating Procedures (SOP), State Laws and Regulations, Team Player, Testing, Time Management, Validation Testing, Writing Skills

LOCATION

RTP, NC

POSTED

7 days ago

QA Contractor, GMP Quality Assurance
RTP NC 27709
8-9 Months (Possible Extension)

Description:
The QA Contractor, GMP Quality Assurance, reporting to the Manager, GMP Quality Assurance, or designee, will be responsible for assisting in the management of AskBio’s Quality Management System (QMS) and will strongly support AskBio’s Culture of Quality. This role will assure corporate compliance with applicable GMP national, international, and state regulations. This position will be based at our headquarters facility in RTP, NC with domestic travel (less than 10% of the time) expected.

Job Responsibilities
· Manage assigned day-to-day QA responsibilities in support of the company’s Quality Management Systems (QMS).
· Provide timely support of Learning Management System, Change Control, Deviation Management Systems, or other QMS based customer requests. Liaison with applicable department record owners to ensure their complete and timely resolution. Review and Approve said record types as assigned.
· Provide accurate and timely weekly and quarterly QMS metric and Key Performance Indicator updates to QA and CMC senior management.
· Collaborate successfully with the other departments to ensure that direct and supportive tasks are completed within project timelines. Providing deliverables and resolving issues; Draft SOPs/controlled documents as well as perform quality unit review and approval of Quality Management Systems requests/ records related to Learning Management, Non-Conformance Management, CAPA management, and metric/KPI reporting.
· Continually evaluate systems and procedures for improvement for efficiency and compliance to applicable regulatory requirements and standards.
· Participate in project meetings as a Quality Unit representative and support colleagues by acting as a technical resource for quality and compliance related issues.
· Perform daily customer-facing activities, as assigned by area management. Maintain health of customer-facing activities such as document archival activities and notebook/logbook assignment and management.
· Identify and collaborate with colleagues to implement continuous improvement initiatives; provide Quality Unit oversight of QMS based activities.
· Assist in the qualification and oversight of vendors, contract manufacturers, contract laboratories, and service providers.
· Support regulatory (FDA, EMA) and internal audits/inspections per AskBio procedures and applicable regulatory requirements.
· Communicate project status to stakeholders and escalate issues in a timely manner.
· Perform and support other duties as assigned by area management.

About you
· Bachelor’s degree in a scientific field and 4+ years of experience in GMP based Quality Assurance, particularly in support/oversight of a company QMS, or 10+ years of GMP based Quality Assurance experience using a company QMS.
· 3+ experience working within a pharmaceutical/biotech Quality Management system, such as Trackwise, ZenQMS, Veeva, is a requirement
· Strong understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to U.S. standards, and where appropriate, other regulatory authority standards.
· Ability to author, review, and interpret Standard Operating Procedures (SOPs).
· Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner.
· Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment.
· Strong service-oriented mindset with excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues.
· Experience in analytical method validation and QC testing, especially in the fields of mammalian cell culture and Gene Therapy/Biologics based potency testing, is preferred.
· Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).

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Why TalentBurst?
At TalentBurst, we deliver more than talent, we deliver outcomes. We partner with you to move quickly and connect you to opportunities aligned with your skills and long term growth.

Backed by precision, transparency, and results, we connect top talent with leading organizations through trusted partnerships.

We offer competitive compensation and comprehensive benefits, including medical, dental, vision, and retirement options.

TalentBurst is an equal opportunity employer committed to an inclusive and diverse workforce.

About the Company

TalentBurst, Inc.

For over 20 years, TalentBurst Inc. has been an award-winning provider of cutting-edge Workforce Management Solutions. With a strong commitment to staying ahead in the tech landscape, we pioneer innovative approaches to talent acquisition. Our expertise spans Life Sciences, and Healthcare Staffing, Banking, Financial, IT, and Engineering, as well as Global Employer of Record (EOR), Agent of Record (AOR), State, Local Government and Education (SLED), and IC validation/compliance services. Additionally, our division, TalentProcure, leads the industry with offerings such as High Hazard Payroll, Managed Services, and Vendor on Premise (VOP) solutions.

Due to our prioritization of excellent standards, we are Joint Commission Certified and are a certified Minority Business Enterprise (MBE) in the USA and Canada. Supporting over 130 Fortune 500 companies globally, we excel in navigating the landscape of talent acquisition. In a world of constant change, we embrace developing people-centric solutions that address the unique demands of our clients. Stay connected by visiting our website and following us on social media!

COMPANY SIZE

5,000 to 9,999 employees

INDUSTRY

Staffing/Employment Agencies

FOUNDED

2002

WEBSITE

http://www.talentburst.com/

QA Contractor, GMP Quality Assurance

TalentBurst, Inc.

RTP, NC

About the Company

TalentBurst, Inc.

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