Quality Specialist Job Vacancy in Smith & Nephew Fort Worth, TX 76107 – Latest Jobs in Fort Worth, TX 76107 – updated today

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Company Name : Smith & Nephew
Location : Fort Worth, TX 76107
Position : Quality Specialist

Job Description : Role Overview:

As a member of the Quality Assurance Team, this position will help determine disposition of final product and ensure compliance with Quality Assurance (QA) policies and procedures, cGMPs, Good Distribution Practice (GDP) and SOPs in both Fort Worth and TJ Smith & Nephew QMS.

Responsibilities:

Review and approval of finished product batch records & lab data and perform periodic product reviews.

Interact with all 3rd party manufacturers in areas of product release and QA issues and drive these issues to resolution

Analyzes, evaluates, presents and escalates to management, any identified risks, improvement opportunities and/or compliance concerns associated with Smith & Nephew’s quality systems. (Focused on Deviation, Investigation and CAPA systems).

Participates in internal and external audits as needed

Follow up on and drive to closure the formal investigations in response to Out-of-Specification (OOS) events; prepare and evaluate CAPA responses.

Supports QA in the timely implementation, assessment and closure of product related projects and operations.

Location:

US – Fort Worth, TX

Education:

Bachelor’s Degree in Life Sciences or Engineering

Experience:

2 to 5 years of industry experience pharmaceutical or medical device experience supporting manufacturing operations to include a variety of the following:

batch record review and approval; lot release; non-conformance investigation process; CAPA; change control; validation, method and protocol review and approval, SOP review, writing and approval.

Competencies:

Demonstrate a technical understanding and knowledge of pharmaceutical facilities, equipment and quality systems.

Demonstrated knowledge of cGMPs, FDA, GDP and rest of world regulatory agency requirements sufficient to apply to quality operations and compliance.

Excellent computer systems and MS Office skills with working knowledge of computer related databases.

The ability to effectively build and maintain relationships within a highly matrix team in order to effectively negotiate and solve problems.

The ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and implement decisions.

The ability to organize, prioritize and deliver tasks & projects with a sense of urgency.

The ability to communicate both verbally and in writing with all levels both inside and outside of the organization.

The ability to maintain an attention to detail while executing multiple tasks.

The ability to exhibit flexible thinking.

A continuous improvement and quality mindset and a willingness to develop yourself and others

Physical Demands:

General office Demands – large percentage of time performing computer-based work; close vision (clear at 20 inches or less) required to review documents and operate computers, sitting for long periods of time

Walk/Stand for continuous periods of time

Travel

<10% Smith+Nephew provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability. This post is listed Under Jobs in general jobs Post Tags : , Fort Worth, TX 76107, jobs in Fort Worth, TX 76107, Quality Specialist jobs in Fort Worth, TX 76107

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