Quality Assurance Manager

Lampire Biological Laboratories•Coopersburg, PA

19h

About The Position

The Quality Assurance Manager is responsible and accountable for quality tasks and operations performed independently or by the Quality Assurance team. Possesses and applies a broad knowledge of Quality principles, practices and procedures. Supports change control process, CAPA system, deviation process, nonconforming material process, customer complaints, supplier approval, material receiving, internal audit process and document control. Requires experience in ISO-9001 or ISO 13485 plus demonstrated familiarity with standard quality concepts.

Requirements

Minimum of 5 years of experience in Quality Assurance managerial role
Experience with ISO9001 and/or ISO13485.
Experience with client and regulatory audits/inspections.
Possess great attention to detail.
Must be able to work independently with minimal direction or oversight.
Good organizational skills with ability to manage multiple priorities.
Well organized and detail oriented professional with strong written and verbal communication skills
Windows-based computer skills, familiarity with Microsoft Word and Excel.
4 year college degree in quality/compliance related field or science-related field
Must be able to lift up to 25 pounds at a time.
Must be able to access and navigate each department at the organization's facilities.

Nice To Haves

Experience with USDA regulations for animal blood products preferred.

Responsibilities

Responsible for QA staff members
Must be able to take a leadership role in Quality related decisions.
Monitor performance of the company Quality Objectives
Preparation, coordination, reporting and follow-up on all assigned Management Review action items.
Participate in internal and external audits, as needed, with potential opportunities to lead audits
Complete custom concern documentation, which may include interaction with internal and external customers
Ensure completion of timely root cause analysis and establish in-depth and robust CAPAs for both internal and externally identified nonconformances or complaints
Oversee, and assist when needed, with the timely and thorough release of products at respective facilities, ensuring paperwork is completed accurately, neatly and fully.
Oversee, and assist when needed, with the material receiving process at respective facilities, ensuring compliance with supplier specifications
Ability to evaluate unplanned deviations, change controls, validations and other technical documents/reports to identify errors and/or potential non-compliance issues and to assess potential product/process risk prior to implementation approval
Coordinate supplier approvals with supplier management staff
Ensure the record retention program is being adhered to
Write, revise and review standard operating procedures (SOPs) and custom specifications.
Become thoroughly knowledgeable of the applicable SOPs and maintain that knowledge base.
Must be able to travel between facilities.
Other duties as assigned