Quality Assurance Specialist

SHL Medical is a world-leading provider in the design, development, and manufacturing of advanced self-injection devices. With a global team of 6,000 employees, we partner with leading pharmaceutical and biotech companies to deliver innovative autoinjectors, pen injectors, and other drug delivery systems that ensure effective treatment for patients. Headquartered in Switzerland since 2018, with key operations in Sweden, Taiwan, and the US, we are united by a commitment to innovation, impact, and growth.

About the role

A QA Specialist provides oversight of GMP operations to ensure that products are manufactured according to cGMP requirements and fit for their intended use. Maintains data collected from the manufacturing process, generates and updates procedures, and ensures Batch Records comply with established policies. Additionally, the QA Specialist will support Design Transfer Activities through product commercialization.

Responsibilities

• Review and approve Production Batch Records and Testing Results to ensure they are complete, accurate, and documented according to established procedures.
• Prepare Certificates of Conformance (CofC) and Certificates of Analysis (CoAs).
• Maintain QA manufacturing floor presence in support of manufacturing operations and provide oversight over process-related decisions.
• Review and approve Quality Work Instructions (QWIs), Technical and Product Specifications, Sampling instructions, and Test Methods.
• Provide oversight to the Design Transfer process, including deliverables such as Plans, Qualification Protocols, Risk Assessments, Technical specifications, procedures, and process validation documentation.
• 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 ensure completion of related corrective and preventive actions.
• Support the Audit Team during external and internal audits.
• Provide support to the program management office with the review and approval of the design transfer package documentation.
• Provide Quality support throughout the product lifecycle, including the review of Annual Product Reviews, Product Process Monitoring activities, and Continuous Improvement initiatives.
• Support training of new QA operations team members and serve as a mentor for documentation practices in Quality culture.

Requirements

• Preferred BS in Engineering, Biology, or other technical-related degree.
• 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 the ability to shift priorities.
• Demonstrated ability to evaluate and apply compliance requirements/guidelines to complex situations.
• Knowledge of regulations and practices pertaining to pharmaceutical/medical device products in the area of responsibility: 21 CFR Part 11, 21 CFR 210 and 211, 21 CFR 820, and ISO 13485.
• Ability to interact with regulatory agencies; knowledge of FDA, EMA, JP, HC, and other regulations.
• Knowledge of Good Manufacturing Practices (GMP) & Good Documentation Practices (GDP).
• Able to communicate effectively and work within cross-functional teams.
• Excellent oral and written communication skills with strong technical writing experience.
• Experience in internal/external audits, identifying findings, driving resolution, and providing closure reports.
• Proficient skills in solving complex problems and ability to bring issues to resolution.
• Experience working globally with diverse teams and cultures.

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.

This offer of employment is contingent upon successful completion of various preemployment screenings, including a drug test, employment verification, reference checks, and a criminal background check.