Quality Assurance Specialist

About the role

The Quality Assurance Specialist provides advanced quality assurance support across manufacturing and quality to ensure products, processes, and documentation meet established internal, customer, and regulatory requirements.

This role independently reviews quality records and product release documentation, leads or supports investigations and corrective actions, analyzes quality trends and risks, and supports internal, supplier, and external audits. This position collaborates with Manufacturing, Quality, and other cross-functional departments.

The Quality Assurance Specialist applies quality system knowledge and risk-based decision making to resolve complex quality issues, improve processes, and maintain compliance with applicable Quality Management System requirements, including ISO 9001 and ISO 13485.

To perform this job successfully, an individual must be able to capably perform each of the following essential duties:

• Review and approve quality and product-release records, including batch records, QC results, environmental monitoring records, and related documentation, to verify compliance with internal specifications, customer requirements, procedures, and established standards
• Independently investigate quality issues, nonconformances, deviations, and customer complaints; partner with cross-functional teams to determine root cause and identify appropriate actions to address product and process concerns
• Initiate and support Corrective and Preventive Actions (CAPAs), including documenting investigations, determining appropriate corrections and corrective actions, monitoring implementation, and supporting timely and effective resolution of quality issues
• Review quality data and metrics to identify trends, recurring issues, and emerging risks, and recommend actions to improve product quality, process performance, and overall Quality Management System effectiveness
• Investigate quality issues and trends from customer complaints, NCMRs, CAPAs, and other quality records
• Review risk management documentation and actions for completeness, feasibility and adequacy. Track mitigation efforts to reduce medium and high risks to acceptable levels
• Identify improvements to reduce scrap, rework, complaints, and other sources of Cost of Poor Quality (COPQ) in line with quality and cost reduction initiatives
• Review and approve Document Change Requests (DCRs) related to materials, production processes, and test methods
• Initiate SOP changes to streamline, standardize, and improve quality system processes
• Support new product development and design-control activities by participating in cross-functional reviews and completing assigned Quality Assurance deliverables to ensure quality requirements are incorporated throughout product development
• Perform internal and supplier audits, issue audit reports, and follow up to close out actions which address the findings
• Provide training and support for quality concepts and tools
• Support New Product Development to include attending design control meetings and completed Quality Assurance Deliverables
• Support and Host External Audits
• Perform other duties as required, or assigned by management, to meet business needs

Essential Knowledge and Qualifications

• Associate's degree in a Technical, Scientific, Quality, or related field - or equivalent combination of relevant education and applicable work experience
• 5+ years of experience in a cGMP or regulated environment, eg. governed by ISO 9001, or ISO 13485
• Experience in root cause analysis and corrective action within a GMP setting
• Direct audit experience as either a lead auditor or part of the audit team

Desired Knowledge and Qualifications

• Prior experience in the medical device, biotechnology, or biopharma industry
• Prior experience in an ISO or FDA-certified manufacturing environment
• Demonstrated experience with electronic platforms for quality management systems
• Proficient computer skills, including working knowledge of Microsoft Office suite of products, particularly Word, Excel, and PowerPoint

Behavioural and Interpersonal Competencies

• Resonate and operate in line with LGC's core value behaviors: Passion, Curiosity, Integrity, Brilliance, and Respect
• Focused on problem solving, including problem definition, risk evaluation, and risk-based resolution
• Strong analytical and examination capabilities for complex projects; ability to develop process maps, organize data, evaluate options, document plans, and communicate progress
• Ability to track and complete multiple priorities independently in a home-based environment with minimal supervision, while maintaining accountability for deadlines and communicating progress.
• Strong interpersonal, organizational, verbal and written communication skills
• Demonstrates curiosity, adaptability, and commitment; collaborates effectively with geographically distributed teams and actively builds relationships through virtual communication.
• Ability to ask probing questions to understand unstated expectations and underlying issues, understand competing priorities, and facilitate discussions to gain consensus through the problem-solving process.
• Oriented to continuous improvement with desire to balance the level of control and flexibility in systems based on risk
• Impeccable attention to detail

Pay and benefits

Typical starting pay for this position ranges from $28.00-$35.00 per hour, based on relevant experience, education, skills, and internal equity. The fully established pay range for the position extends up to $42.00 per hour.

This position is eligible for a discretionary bonus program. Participation in the bonus program is not guaranteed, and bonuses are awarded at the discretion of the company based on individual and company performance result.

What we offer (US based employees)

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid short- and long- term disability, life insurance, and employee assistance program
• Flexible work options
• Pet Insurance for our furry friends
• Enhanced Parental leave of 8 additional weeks
• PTO that begins immediately
• Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Companywide social events, frequent catered lunches and much more!