Quality Assurance Specialist I

The QA Specialist I position will advance LGC Clinical Diagnostics purpose of understanding disease to  enable  precision  diagnostics  by supporting and contributing to LGC Clinical Diagnostics product quality and Quality Management System processes. LGC Clinical Diagnostics Milford location is seeking a candidate who is experienced with a working knowledge of quality system requirements including FDA QSR / cGMP ISO 13485 and ISO 14971. The successful candidate will have a strong orientation toward root cause analysis continuous improvement based on predictive and preventive metrics. The ideal candidate will be able to support and collaborate with commercial and manufacturing teams to ensure customer requirements are translated into internal specifications with continuous feedback loops for evaluating product and process performance.

Key Responsibilities

• Provide QA support on cross functional teams in investigations of deviations nonconformances OOS and CAPAs to determine root cause and implement corrective actions to mitigate root causes; work constructively with functional groups to determine root causes for process issues related to products and services.
• Ensure accurate QMS records related to non-conformances deviations customer complaints OOS reworks and CAPAs; work with functional groups to determine root causes for process issues related to products and services.
• Investigate quality issues and trends from customer complaints NCRs CAPAs etc. to identify actions required.
• Perform product release activities such as review of batch records QC results and environmental monitoring records. Assess excursions with appropriate deviations and / or risk evaluations.
• Review risk management documentation and actions for completeness feasibility and adequacy. Track mitigation efforts to reduce risks to acceptable levels.
• Review and approve Document Change Requests (DCRs) related to materials production processes and test methods.
• Accurate review and approval of records comparing results to internal and customer specifications SOPs and established standards for product release.
• Perform internal and supplier audits issue audit reports and follow up to close out actions which address the findings.
• Provide support on quality concepts and tools.
• Update and track metrics for trending and reporting.
• Provide QA on-the-floor support including inspection of raw materials and finished product

Qualifications :

Minimum Qualifications :

Bachelors Degree with at least 2 years Quality Assurance experience.

Passionate about addressing issues which involves defining problems assessing risks and finding risk-based solutions. Proficient in root cause analysis.

Strong interpersonal organizational verbal and written communication skills.

Demonstrates curiosity adaptability and dedication; works best in a team environment and actively seeks to foster relationships.

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.

Outstanding attention to detail.

Strong analytical and examination capabilities for complex projects desired; ability to develop process maps coordinate data evaluate options document plans and communicate progress.

Preferred Qualifications :

Minimum of 2 years of experience in a cGMP environment governed by 21 CFR 210 / 211 21 CFR 820 or ISO 13485.

Additional Information :

The customary salary range for this position is :

Minimum pay rate : $60000 USD

Maximum pay rate : $81000 USD

The salary range provided covers the minimum and maximum amounts projected for this role. The base salary will be influenced by factors like experience skills and location.

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

Join LGC and become part of a team that values collaboration integrity and brilliance in all we do. We are committed to encouraging a workplace where everyone can thrive and contribute to our mission.

Our values :

PASSION

CURIOSITY

INTEGRITY

BRILLIANCE

RESPECT

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 parental responsibilities 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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Remote Work : No

Employment Type : Full-time

Key Skills

Invoicing,Information Technology Sales,IT Support,Audio Visual,Database Administration

Experience : years

Vacancy : 1