Quality Assurance Manager - Tallahassee, United States - X4 Life Sciences

X4 Life Sciences Tallahassee, United States

1 week ago

Description

X4 Life Sciences has just partnered with a leading Pharmaceutical Manufacturing firm who provide ethically-sourced, high quality human-based biologicals to the in vitro, diagnostic and research markets.

Established in 1970, our client has a long history of providing quality human biologicals to those who need it.

As the first ISO 9001 Blood Bank in the world, they continue to stay one step ahead of similar providers, both smaller and larger.

Therefore, this Quality Assurance manager vacancy is a key role to administer and fulfill all the regulatory and standards requirements of their Quality Management System (QMS).

This role is responsible collectively with the Quality Assurance Director maintaining the QMS, keeping the document review cycle up to date, and addressing/updating open issues timely reflecting commitment to Quality Policy.

Job Duties & Responsibilities:
Plan, conduct, and report internal or external quality audits, including the creation and tracking of related corrective actions.
Update issues in the QMS and provide assistance to SMEs and other assignees to complete tasks following procedures and standards, including appropriate root cause analysis

Maintain the document review cycle documents and prioritization matrix up do date by continuously communicating with assignees and senior managers in order to streamline the review process.

Create, update and conduct all the validation protocols for critical equipment and software and plan in alignment with departmental managers that validations are effectively completed in a timely fashion.

Assists the QA Director and/or Senior Management with compliance activities, audits, documentation and communications with external regulatory bodies and standards organizations (FDA, ISO, COLA/CLIA and other regulatory bodies).

Qualifications :
BA or BS in Biology, Sciences, Quality Management, Engineering, Business Administration or similar field

6 -10 years of experience in Quality Assurance, preferably in a related field to Blood Banking, IVD, or Pharmaceutical/R&D institutions.

Knowledge of safety requirements and legal standards from FDA, CLIA/COLA, ISO 9001 preferred.
Experience analyzing and navigating through regulatory requirements contained in the CFRs
Knowledge of standards and regulatory framework, especially regarding Biological products.

Please note, our client is seeking a professional who is either located in or willing to relocate to Florida.

Apply within...

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