Quality Assurance Specialist

LGC Group; Alexandria (MN); On-site; USD 39,000 - 48,000; Full time

Benefits offered by this job

Medical benefits

Dental & Vision

401(k) retirement plan

Flexible work options

PTO

Job summary

LGC Group is seeking a Quality Assurance Specialist in the United States to provide advanced QA support across manufacturing and regulatory affairs. The role reviews quality records, leads investigations, supports internal and external audits, and improves processes in line with ISO 9001 and ISO 13485.

Responsibilities include approving release records, investigating quality issues, initiating CAPAs, and tracking risk mitigation. Strong collaboration with cross-functional teams is essential.

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, e.g. 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
• Demonstrated experience with electronic platforms for quality management systems

Responsibilities

• Review and approve quality and product-release records to verify compliance with internal specifications and customer requirements
• Investigate quality issues, nonconformances, deviations, and customer complaints with cross-functional teams
• Initiate and support CAPAs, documenting investigations and monitoring implementations
• Review quality data and metrics to identify trends and risks and improve product quality and QMS effectiveness
• Perform internal and supplier audits, issue audit reports, and close out actions

Skills

Experience in cGMP environment

Root cause analysis

Audit experience (lead auditor or team

Education

Associate’s degree in technical/scientific/quality field

Tools

QMS software

Job description

• Department: Quality Assurance and Regulatory Affairs

Job Description

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

Qualifications

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

Additional Information

Pay Disclosure:
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.

E-Verify:

LGC participates in E-Verify to confirm the identity and employment eligibility of newly hired employees.

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!

Equal opportunities

LGC strongly believes that every job applicant and employee should be valued for their individual talents regardless of age, disability, race, color, ethnic or national origin, sex, sexual orientation, gender reassignment, marital or civil partnership, pregnancy or parental, religion, or belief. Shortlisting, interviewing, and selection will always be carried out without regard to gender, sexual orientation, marital status, color, race, nationality, ethnic or national origins, religion or belief, age, or trade union membership.

All your information will be kept confidential according to EEO guidelines.