Quality Control Specialist
$30-$35 per hour
Minnetonka, MN – Onsite
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