Quality Assurance Specialist II

Company overview: ALPCO Diagnostics sells immunoassay kits (ELISA/RIA) as well as antibodies and recombinant proteins to the life science and medical diagnostic industries. Customer segments include clinical and hospital reference labs, Biotech and Pharmaceutical R&D labs and basic academic research labs.

Position: Quality Assurance Specialist II

Reports To: QA Manager

Position Description:

The Quality Assurance Specialist II helps drive product quality and compliance throughout the organization by supporting R&D, production, and the business in alignment with the ALPCO quality system and international regulations. They will also assist in the development, implementation, and coordination of programs to prevent or eliminate defects in new or existing products at ALPCO.

Responsibilities:

• Assure ALPCO products and employee activities are documented and are in compliance with ALPCO’s quality system.
• Participate in review and improvement of the ALPCO Quality System documentation in compliance with current regulations, standards, and guidance documents.
• Review of batch records, validations, and risk files to ensure quality and compliance.
• Lead CAPAs on subjects related to quality and the Quality System
• Oversight of supplier records and documentation
• Assist with internal audits as required by management.
• Participate in FDA and ISO notified body audits.
• Responsible for establishing and meeting timelines of assigned work.
• Will act as a signature authority on all documents requiring a signature from the QA representative.

Skills & Qualifications:

• Bachelor’s degree in the Sciences or a related discipline preferred; 5-7 years equivalent relevant experience.
• Understanding of FDA QSMRs (CFR Part 820) and ISO 13485.
• Must be a results-driven individual with good attention to detail.
• Previous experience and understanding of product flow in a diagnostics or medical device company preferred.

**Eligibility & Compliance: Candidates must be authorized to work in the United States without need for current or future sponsorship. Employment is contingent upon successful completion of applicable pre-employment requirements, which may include background checks and verification of work authorization.
ALPCO is an equal opportunity employer and does not discriminate based on any protected status.

Pay: $65,000.00 - $90,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Work Location: In person