Quality Assurance Specialist

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: 

• Associates 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 LGCs 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 

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.

For more information about LGC please visit our website 

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

Remote Work :

No

Employment Type :

Full-time