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SHL Medical · 20 hours ago

QA Specialist

Deerfield Beach, FL

Full-time

Onsite

Mid Level

4+ years exp

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. The QA Specialist provides oversight of GMP operations to ensure that products are manufactured according to cGMP requirements and fit for their intended use, while maintaining data and ensuring compliance with established policies and procedures.

ManufacturingMedical Device

H1B Sponsor Likely

Responsibilities

Review and Approve Production Batch Records and Testing Results to ensure they are complete, accurate and documented according to established procedures

Prepare CofC and CoAs

Maintains QA manufacturing floor presence in support of manufacturing operations and provides oversight over process related decisions

Reviews and approves Quality Work Instructions (QWIs), Technical and Product Specifications, Sampling instructions and Test Methods

Provides oversight to Risk Management programs, procedures, and documentation for Development and Process Validation activities

Review and approve Test Method Development, Validation, and Transfer activities in support of the Analytical Sciences department

Review and approve Stability Studies protocols and reports

Support the investigation process for Non-Conformances and ensures completion of related corrective and preventive actions

Support the Audit Team with during external and internal audits

Provides support to the program management office with the review and approval of the design transfer package documentation

Provides Quality support for throughout the product lifecycle to include the review of Annual product reviews, Product Process Monitoring activities and Continuous Improvement initiatives

Qualification

GMP operationsQuality AssuranceRegulatory knowledgeAudit experienceTechnical writingProblem solvingCross-functional teamworkCommunication skills

Required

A minimum of 4 years of experience in Quality with Pharmaceutical and/or Medical Device based GMP manufacturing operations

Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities

Demonstrate proficient ability to evaluate and apply compliance requirements/guidelines to complex situations

Knowledge of regulations and practices pertaining to pharmaceutical/medical device products in area of responsibility

Ability to interact with regulatory agencies. knowledge of FDA, EMA, JP and other regulations

Knowledge of Good Manufacturing Practices & Good Documentation Practices

Able to communicate effectively and work within cross-functional teams

Excellent oral and written communication skills with strong technical writing experience required

Experience in internal / external audits, identify findings, drive resolution, and provide closure report

Proficient skills in solving complex problems and ability to bring issues to resolution

Experience working globally with diverse teams and cultures

Preferred

BS in Engineering, Biology, or other technical related degree

Benefits

Competitive compensation package

Modern working environment with state-of-the-art facilities and technologies

Challenging assignments in a fast growing and innovative industry

Position in a dynamic, international team of highly skilled professionals

Various opportunities for personal and professional development within a global organization

Company

SHL Medical

SHL designer, developer, and manufacturer of advanced drug delivery devices such as autoinjectors, pen injectors, and inhaler systems.

Founded in 1989

Zug, Zug, CHE

5001-10000 employees

https://www.shl-medical.com/

H1B Sponsorship

SHL Medical has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Represents job field similar to this job

Trends of Total Sponsorships

2025 (2)