Overview
HAL Quality Specialist Jobs in Huntersville, NC at BioCytics Inc
The HAL Quality Specialist supports the development, implementation, and ongoing operation of Quality Assurance and Quality Control (QA/QC) activities within the Human Applications Laboratory (HAL). During the laboratory startup and operational readiness phase, this position will play an active role in establishing the Quality Unit QA & QC functions, including developing QC processes and workflows, setting up laboratory equipment, supporting equipment installation and qualification, establishing testing capabilities, developing controlled documentation, and preparing QC operations for GMP manufacturing activities.
The Quality Specialist will assist with the receipt, setup, and operational readiness of new laboratory equipment and support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) activities, as applicable. This position will also support the development and implementation of QC testing methods, SOPs, work instructions, forms, specifications, and other systems necessary to establish a compliant and inspection-ready QC laboratory.
Following establishment of routine operations, the Quality Specialist will perform quality assurance and quality control activities supporting GMP manufacturing and research operations. This includes but is not limited to quality assurance reports, documentation control (Forms, SOPs, Policies, Procedures and Work-Aids), QC testing, review of QC data and documentation, equipment and method qualification, investigations, and product release support for autologous cell therapy products.
The Quality Specialist works collaboratively with HAL Manufacturing, Quality, Research, and other applicable departments to ensure QA/QC activities are established and performed in accordance with approved procedures, applicable regulatory requirements, and established quality standards. This position reports directly to the HAL Quality Manager.
Responsibilities:
- QC Laboratory Startup and Operational Readiness
- Equipment, Method, and Process Qualification
- Quality Control Testing and Routine Operations
- QA/QC Documentation and Quality Systems
- Deviations, Investigations, and CAPA
- Batch Record Review and Data Integrity
- Regulatory, Audit, and Inspection Readiness
- Cross-Functional Support and Continuous Improvement
Competencies:
- Planning/Organizing: Prioritize and plan work activities
- Problem Solving: Identify and resolve problems in a timely manner
- Judgment: Include appropriate people in decision making process
- Multi-tasking: Handle several different tasks simultaneously
- Quality: Demonstrate accuracy and thoroughness
- Adaptability: Able to deal with frequent change, delays, or unexpected events
- Dependability: Commit to long hours of work necessary to reach goals
- Teamwork: Balance team and individual responsibilities
- Quality Management: Look for ways to improve and promote quality
- Safety and Security: Observe safety and security procedures
Qualifications:
- Minimum of 2 years of hands-on experience in a clinical, research, biotechnology, pharmaceutical, cell therapy, or GMP laboratory environment.
- Demonstrated ability to set up, operate, troubleshoot, and maintain laboratory equipment and instrumentation.
- Experience supporting laboratory startup, equipment implementation, or establishment of new laboratory processes is strongly preferred.
- Experience with equipment qualification activities, including IQ, OQ, and PQ, preferred.
- Experience with cell characterization, flow cytometry, or other applicable cellular laboratory techniques preferred.
- Knowledge of cGMP principles, Good Documentation Practices (GDP), data integrity requirements, and laboratory Quality Systems.
- Experience performing or supporting QC testing such as sterility, endotoxin, mycoplasma, viability, or other applicable analytical testing preferred.
- Experience developing, revising, or implementing laboratory SOPs, work instructions, forms, specifications, and controlled documentation.
- Experience with deviations, OOS/OOT investigations, root cause analysis, CAPA, change control, and risk management preferred.
- Experience in cell and gene therapy, autologous cell therapy manufacturing, or personalized medicine programs strongly preferred.
- Experience supporting regulatory, sponsor, or accreditation audits and inspections preferred.
- Familiarity with IND-enabling activities and early-phase clinical development preferred.
- Strong attention to detail and demonstrated ability to maintain accurate, complete, and traceable laboratory documentation.
- Strong organizational and problem-solving skills with the ability to manage multiple priorities during both laboratory startup and routine operations.
- Ability and willingness to perform hands-on laboratory setup activities in addition to routine QC testing and documentation responsibilities.
- Ability to work effectively in a fast-paced, evolving environment and adapt to changing priorities as laboratory operations are established and expanded.
- Strong written and verbal communication skills and ability to collaborate effectively across Quality, Manufacturing, and Research teams.
Education Requirements:
- Bachelor’s degree in Biology, Chemistry, Medical Technology, Medical Laboratory Science, or a related life science discipline required.
Work Location:
- One location
Work Remotely:
- No
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Application Question(s):
- Are you willing to undergo a background check, in accordance with local law/regulations?
- Are you willing to take a drug test, in accordance with local law/regulations?
- Will you now or in the future require employer-sponsored work authorization (e.g., H-1B visa sponsorship) to work in the United States?
Education:
- Bachelor’s (Required)
Experience:
- relevant: 2 years (Required)
Ability to Commute:
- Huntersville, NC 28078 (Required)
Work Location: In person
Title: HAL Quality Specialist
Company: BioCytics Inc
Location: Huntersville, NC
Category:
