Aerotek QC Technician in EASTON, Maryland
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
Prepare inspection sheets and other needed forms using Microsoft Word or
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
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
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
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.
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.