ABEC · 1 day ago
DC Quality Specialist
Bethlehem, PA
Full-time
Onsite
Mid LevelABEC is a leading supplier to the biopharmaceutical manufacturing industry, and they are seeking a Quality Specialist to ensure quality-assurance standards and procedures are met. The role involves maintaining oversight of quality systems, managing audits, and driving QA process improvements.
BiotechnologyInformation TechnologyManufacturing
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
Organise 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 prioritised and acted upon in a timely manner
Execute other tasks as assigned
Ability to travel when required
Qualification
Required
Third Level qualification 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
Excellent written and verbal communication skills
Good organisational skills with the ability to multi-task
Must work well both independently and in a team-oriented, collaborative environment
Company
ABEC
ABEC has been a global leader in delivering integrated process solutions and services for manufacturing in the biopharmaceutical industry.
Founded in 1974
501-1000 employees
H1B Sponsorship
ABEC 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
2023 (2)
Funding
Current Stage
Late StageTotal Funding
unknown2016-09-15Seed
Leadership Team
S
Scott Pickering
CEO & Chairperson
Jack Wilson
Founder and Chairman of the Board
Recent News
Private Equity Wire
2025-06-11
Company data provided by crunchbase