Quality Control Inspector


Job Tasks

Inspect incoming components, in-process product, and finished product according to documented specifications.

Review all documents before the start of production and complete first piece approval (FPA) as required.

Record data and maintain accurate records following GMP good documentation practices

Prepare inspection sheets and other needed forms using Microsoft Word or Microsoft Excel.

Troubleshoot quality concerns that may arise on the production floor Review all paperwork, including device/drug history records (DHR), daily for accuracy and completeness

Verify the calibration of all inspection test equipment and maintain accurate records.

Gather data and investigate relative to customer complaints.

Participate in the execution and documentation of process validations

Assist in maintaining the quality management system to comply with the current ISO standard and applicable FDA GMP Regulations.

Perform data entry and retrieval using the Aphena computer system May be required, as needed, to work overtime, weekends, or alternate shifts.

Perform pre-approval inspections and maintain accurate records.

Assist in the generation and resolution of corrective and preventive action plans (CAPAs)

Assist in the documentation and resolution of nonconforming material reports and process discrepancy reports.

Generate controlled labels as needed using programs provided. Document same using proper approval forms and paperwork to issue and return materials from the Label Control Area.

If necessary, initiate non-conforming or process discrepancy documentation including data entry and labeling requirements. Also responsible for stock segregation if necessary.

Assist in material flows required to maintain label control operations including consolidation, relocation, and other practices.

Maintain work area orderliness and cleanliness.

Qualifications

Job Skills (REQUIRED)

PC proficient (knowledge of Microsoft Word and Microsoft Excel)

Knowledge of FDA Good Manufacturing Practice (GMP) regulations about medical devices and pharmaceuticals.

Knowledge of the International Organization for Standardization (ISO) standard.

Ability to prioritize assignments.

Good communication skills

Good writing skills

Ability to interact with customers and/or vendors on an as-needed basis.

Ability to read and understand drawings and templates.

Manage multiple projects in a time-sensitive environment.

Complete projects on time.

Proven analytical, problem-solving, and troubleshooting skills.

Ability to interact with all levels within the organization.

Ability to train all levels within the organization.

(PREFERRED)

Knowledge of Statistical Process Control (SPC) systems.

Ability to flowchart and graph data.

Personal Attributes

Dependable

Detail-oriented

Flexible

Energetic

Self-starter

Trustworthy

Works well with others

Works well under pressure

Good communication skills

Ability to prioritize tasks

Ability to make decisions

Physical Requirements

Receive instructions through oral communications accurately and quickly.

Convey answers or instructions to other workers accurately, loudly, and quickly.

Must be able to lift and move materials up to a maximum of 50 pounds.

Will be subject to dust, perfumes, and chemicals.

Will be exposed to inside and outside environmental conditions.

The physical activity of this position includes, but is not limited to: Climbing, Walking, Stooping, Kneeling, Crouching, Reaching, Standing, Pushing, Pulling, Lifting, Grasping, Twisting, Sitting, and Feeling.

The inspector should have good visual awareness.

Education/Experience Education

High school graduate required.

Advanced college-level courses, preferred.

Experience

Previous experience working with GMP Regulations about medical devices or pharmaceuticals.

Superior written and verbal communication skills required to communicate issues and procedures among multiple departments. Competent with Microsoft Excel, Word, and the Internet.

Ability to solve complex, multi-layered problems.


?Please contact me at KELT064@kellyservices.com or (302) 323-1560


**Why Kelly** **** **?**


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**About Kelly** ****


At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/non-traditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce and providing accommodations for people with disabilities in all parts of the hiring process as required under its Employment Accommodation Policy. Kelly will work with applicants to meet accommodation needs that are made known to Kelly in advance.