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Aerotek QC Technician in EASTON, Maryland

Description:

Inspect incoming components, in-process product, and finished product according

to documented specifications

Review all documents prior to the start of production and complete first piece

approval (FPA) as required

Record data and maintain accurate records in accordance with 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 be in compliance with the

current ISO standard and applicable FDA GMP Regulations

Perform data entry and retrieval using the proprietary 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

Skills:

documentation process, gmp, quality control, quality inspection, data entry, pharmaceutical, biotechnology

Top Skills Details:

Candidates will be inspecting incoming components, in-process products, and finished products according

to documented specifications.

Additional Skills & Qualifications:

PC proficient (knowledge of Microsoft Word and Microsoft Excel)

Knowledge of FDA Good Manufacturing Practice (GMP) Regulations pertaining to

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 trouble-shooting skills.

Ability to interact with all levels within the organization.

Ability to train all levels within the organization.

About Aerotek:

We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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