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Supplier Quality Assurance (SQA) Manager - #1216

Company: Medical Engineering Consultants
Location: Boca Raton
Posted on: May 8, 2022

Job Description:

Summary :
This position involves daily management of Supplier Quality Assurance (SQA) processes to ensure compliance with applicable company and regulatory requirements, standards, guidance and procedures for development and manufacture of drugs and biologics.
Task will involve maintaining consistent and compliant execution of the SQA processes and quality systems pertaining to identification, qualification, approval, and continuous monitoring of suppliers and service providers.

Ensure cGMP and regulatory compliance as defined in FDA regulations such as 21 CFR Parts 11, 210, 211, 600 and 640, as well as compliance with corporate policies, standards, and procedures.
Maintain and update the approved supplier list (ASL) to ensure suppliers and service providers are appropriately classified, qualified, monitored and maintained for the products and services provided.
Monitor and execute supplier quality agreements to ensure compliance with policies and procedures.
Manage on-time execution of the supplier CAPA process (SCARs) and work with suppliers to resolve non-conformances and deviations.
Maintain supplier performance files (e.g., supplier scorecard) and communicate SQA KPIs to senior management during Management Review meetings.
Manage the performance review of suppliers, to enable full transparency of suppliers' performance across the stakeholders to drive supplier improvement, where necessary.
Create and maintain annual audit plans for internal and external audits.
Perform internal and external audits to ensure adherence to the approved audit plan, policies and procedures, and applicable FDA regulations and guidance.
Prepare and communicate supplier notifications and applicable external audit metrics (i.e., audit & report completion, schedule adherence, audit CAPA plan(s), etc.).
Perform product quality complaint investigations.
Administer Material Review Board (MRB) meetings.
Support Supply Chain and QA Compliance needs and ensure compliance with regulatory requirements related to suppliers and service providers.
Coordinate and perform any additional activities or cross-functional continuous improvement projects assigned by QA management.
Escalate issues to quality management in timely manner and work with management to address and remediate issues.
Daily contact with professional staff, peers, and senior management to exchange information, resolve problems, coordinate projects, and negotiate solutions to ensure quality and regulatory compliance. Regular contact with Senior Management to provide information.
Routine contact with vendors, suppliers, contract testing laboratories and contract manufacturers to provide and collect information, coordinate audits, solve problems and negotiate solutions on policy guidelines and changes.
Direct work of SQA Specialist(s) and third-party external auditor(s), as needed.

Bachelor's degree in science or related technical field required.
Minimum 5-7 years of experience in pharmaceutical or biotechnology industry or other related industry. Experience in supplier quality management.
Detail oriented, and has knowledge of scientific, medical, and regulatory terms.
Ability to use personal computer and software including word processing, spreadsheet, and database.
Demonstrated organizational and coordination skills, with close attention to detail and accuracy.
Good interpersonal and oral communication skills to effectively train personnel.
Demonstrated good problem-solving skills with minimal supervision.
Mathematical skills including the use of calculations involving fractions, decimals, and percentages.

*Sponsorship is not available for this position
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Keywords: Medical Engineering Consultants, Boca Raton , Supplier Quality Assurance (SQA) Manager - #1216, Executive , Boca Raton, Florida

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