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Quality Assurance Specialist II

Eingestellt von Software Specialists

Gesuchte Skills: Support, Consultants



IT Staffing Done Right the First Time

Software Specialists is an IT staffing company with extensive consulting experience in the Information Technology Industry. Incorporated in the state of Pennsylvania in 1998, we bring 15 years of experience in providing IT talent to FORTUNE 1000 Companies.

Our experience from providing thousands of IT consultants has taught us that customers require contractors with more than just the technical knowledge. Team work, cultural fit, and attitude are just as important as aptitude. Be it 1 position or 100 positions, Software Specialists' focus is on finding the "Smart Fit" for our clients' needs; this makes us not just one of the fastest growing Information Technology consulting firms in the country but also a trusted adviser to our customers in their talent acquisition process.


PAY RATE: $19.48/HR ON W2


The QA SPECIALIST is primarily responsible for Document Control activities, including maintenance of the Complaint, CAPA and Training systems. The QA Specialist also provides Administrative support to the department in terms of compilation of the various reports required both internally within the department and externally.

* Leading the maintenance of Quality Assurance System databases, including but not limited to:
Ø Document Control and MyWorkshop database maintenance
Ø Complaint delegation and CSSx database maintenance
Ø CAPA investigation and TrackWise database maintenance
Ø Audit Metrics
Ø Production and Process Control Metrics
Ø Training workflow submission and record retention
* Supporting the preparation of Quality Management Reviews at the site

Quality Specific Goals:
1. Process all quality management system document changes according to requirements
2. Ensure on-time reporting of the CAPA, Complaint and Training monthly metrics
3. Aware of and comply with the Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position
4. Complete all planned Quality & Compliance training within the defined deadlines

1. Experience with DOCUMENT CONTROL, CAPA, Complaint and Training systems.
2. Experience in investigation of cases and discernment in referral to subject matter experts
3. Proficient with MS Office word processing, spreadsheet, presentation, and database applications.
4. Able to identify root cause of problem and creatively problem solve to gain resolution.
5. Able to communicate effectively in English (both written and oral).
6. Able to work independently in fast-paced environment with little supervision.
7. Able to adapt to constant change and influence positive change effectively.
8. Team-oriented and responsive to customer needs.
9. Quality-Focused, Attentive to Detail and Results-Oriented.

Preferred Qualifications:
1. Experience complying with quality regulations in QA role (including FDA QSRs, ISO13485).
2. Experience in a medical device or pharmaceutical industry.
3. Statistics education and or training
4. Experience developing and tracking quality metrics
5. Familiar with Continuous Improvement methodologies including Six Sigma
6. B.S. Degree in business or technical field

KEYWORDS: CAPA, QMS, Quality Assurance, Medical, Pharma


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