Company Background:

ABEC has been a leading supplier to the biopharmaceutical manufacturing industry for over 50 years. ABEC's unique value is based on combining long experience with the ability to engineer, design, manufacture, commission, qualify, and service the entire bioprocess to reduce overall cost, shorten time to market, and maximize productivity. ABEC's products include process and equipment engineering/consulting services, comprehensive site services, bioreactors and fermenters, filtration and chromatography systems, prep and hold systems, and cleaning/sterilization systems.

Position Summary:

The Quality Specialist will work under the direction of the DC QA Manager to ensure ABEC quality-assurance standards and procedures are met. Review standards, policies, and procedures, as well as carry out programs to evaluate the effectiveness of existing programs and write new standards and procedures as necessary.

Responsibilities:

• Maintain an active oversight of the quality systems to ensure it is fit for purpose and ensures compliance with procedures, requirements and best practice.
• Organize and manage site preparation and manage audit back rooms for Regulatory and Corporate Audits.
• Provide Quality Assurance support to all areas of quality department, ensuring compliance is maintained at all times.
• Identify, lead and drive QA process improvement initiative as appropriate.
• Prepare, implement and analyse key Quality Systems related documentation.
• Maintain and support to the Corrective and Preventive Action (CAPA) program.
• Maintain and support the Non-conformance program.
• Delegate for the Manager, Quality Assurance, CMEU.
• Prepare Management Review presentations as appropriate.
• Provide meaningful Quality Assurance measurement while ensuring that in-house or external Quality issues are effectively prioritized and acted upon in a timely manner
• Execute other tasks as assigned.
• Ability to travel when required.

Qualifications:

• Bachelor's degree in Quality, Science, Engineering or other relevant technical discipline.
• Qualified and experienced Lead Auditor, preferably within the medical device industry.
• Proficient with Microsoft Office applications; including Word and Excel.
• Infor Syteline ERP Software experience preferred.
• Excellent written and verbal communication skills.
• Good organizational skills with the ability to multi-task.
• Must work well both independently and in a team-oriented, collaborative environment.
• Execute other tasks as assigned.