Onsite Senior QA – Biotech Manufacturing & PQA

Global Technical Talent, an Inc. 5000 Company; Holly Springs (NC); On-site; USD 41,000 - 48,000; Part time

Benefits offered by this job

Medical, Vision, and Dental Insurance

401k Retirement Fund

Job summary

Global Technical Talent, an Inc. 5000 Company, is seeking a Sr. QA Associate for Manufacturing and PQA on the floor in Holly Springs, NC.

The role ensures GMP quality across new product introductions, deviations, and quality systems, coaching manufacturing staff and driving compliant processes. Responsibilities include real-time decision-making, cGMP oversight, CAPA closure, change control, audits, and cross-functional collaboration between Manufacturing and Quality teams to sustain product

Qualifications

• Strong cGMP and GDP behaviors.
• Experience in biotechnology; knowledge and process experience within a cGMP manufacturing facility or other highly regulated environment.
• Technical understanding of upstream and/or downstream manufacturing within a biotechnology production operation.

Responsibilities

• Quality oversight of new product introduction activities covering facilities, utilities, equipment, systems, and process with alignment into the Amgen Quality Systems; may include support on commissioning and qualification and validation activities in addition to new document support.
• Provide ongoing Quality oversight to ensure products are manufactured, tested, stored, and distributed according to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), and other applicable regulations
• Ensure that facilities, equipment, materials, organization, processes, and procedures comply with applicable regulations and requirements relating to Good Manufacturing Practices, Good Documentation Practices, Safety, and other controls
• Drive closure/completion (including review and approval) of cGMP processes, procedures, documents, and records, including but not limited to deviations, investigations, corrective action/preventative actions (CAPAs), change control records, and validations
• Ensure production and testing records/results are complete, accurate, and documented according to procedures, GDP, and cGMP requirements
• Oversee and provide guidance during on-the-floor analytical testing
• Ensure that changes that could potentially impact product quality are assessed according to procedures
• Ensure that deviations from established procedures are investigated and documented per procedures
• Alert senior management of quality, compliance, supply, and safety risks
• Provide project management support, leading efforts to drive timely achievement of tasks and develop strategies for system implementation
• Identification and implementation of continuous improvement opportunities within our processes and systems
• Support and represent PQA during audits and inspections; may directly interact with regulatory agencies during on-site inspections

Skills

cGMP

GDP

biotechnology experience

upstream manufacturing

downstream manufacturing

MS Office

EBR/MES

DeltaV

Electronic Quality Systems

PQA background

Education

High school diploma/GED

Associate's degree

Bachelor's degree

Master's degree

Tools

DeltaV

EBR/MES

Electronic Quality Systems

Job description

Global Technical Talent, an Inc. 5000 Company, is seeking a Sr. QA Associate for Manufacturing and PQA on the floor in Holly Springs, NC.

The role ensures GMP quality across new product introductions, deviations, and quality systems, coaching manufacturing staff and driving compliant processes. Responsibilities include real-time decision-making, cGMP oversight, CAPA closure, change control, audits, and cross-functional collaboration between Manufacturing and Quality teams to sustain product