Quality Control Specialist

$30-$35 per hour

Minnetonka, MN – Onsite

POSITION SUMMARY:

Maintains quality standards by approving incoming materials, in-process production, and finished products, recording quality results. Assists Quality Engineers with data gathering/analysis and QMS maintenance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Responsibilities include, but are not limited to:

• Approve release of lots at contract manufacturers by reviewing DHRs, confirming specifications, performing visual examination, and taking variable measurements.
• Build product as needed for testing purposes.
• Approve incoming materials by confirming specifications; performing visual examination and taking variable measurements; rejecting and returning unacceptable materials.
• Document inspection results by completing reports, logs, and inputting data into database.
• Monitor incoming product quality and report observations to Quality Engineering.
• Generate NCR/Deviation Reports.
• Assist with Quality System Improvement projects and/or CAPA.
• Modify procedures as appropriate and submits for approval.
• Interface with suppliers regarding lot release and related issues.
• Work with engineers to review new and modified lab procedures.
• Assist in the development of procedures and methods for evaluating and inspecting products and processes.
• Assist with gathering of data and information for use in the generation of periodic performance metrics.
• Conduct training exercises commensurate with area(s) of functional expertise.
• Support facilitation of audits and inspection administered by health authorities, third-parties and partners as assigned by manager.
• Other activities as assigned by departmental management.

EDUCATIONAL REQUIREMENTS (degree, license, certification):

• Minimum high school education.
• Two (2) years vocational technical training or five (5) years applicable experience and knowledge preferred.

YEARS OF EXPERIENCE:

• Five to nine years’ experience working with ISO and GMP systems and requirements.

OTHER SKILLS AND ABILITIES:

• The candidate will be a problem-solver with the ability to exercise sound judgment under challenging circumstances.
• Excellent communication skills with the ability to effectively promote intra-and inter-organizational cooperation.
• Ability to interface with technical services, R&D, manufacturing, and regulatory affairs to accomplish required tasks.
• Ability to communicate with co-workers and management in a professional manner.
• Familiarity with Excel, Access and/or other spreadsheet or relational databases for compilation/trending of data.
• Knowledge of GXP, 21CFR, ISO, QSR and other applicable Regulations, Standards, Directives and Guidance
• Possessing strong character with self-confidence and integrity necessary to ensure that the best-interests of product recipients and customers are always of first and foremost importance.
• Strong background in a manufacturing and operations environment
• Sound technical background and the ability to educate stakeholders, management and customers pertaining to quality assurance/control principles and techniques.
• Ability to interface with internal customers at all levels and 3rd-party partners.
• Ability to travel domestically.
• Light mechanical duties: intermittent stress due to changing priorities and a variety of tasks that need to be completed in a timely manner.

TCWGlobal is an equal opportunity employer. We do not discriminate based on age, ethnicity, gender, nationality, religious belief, or sexual orientation

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