What are the responsibilities and job description for the QA Specialist I position at Select Source International?
Job Title: QA Specialist I
Job Location: Abbott Park IL
Job Duration: 6 months contract (With Possible Extension and/or Conversion)
Job Description
Job Location: Abbott Park IL
Job Duration: 6 months contract (With Possible Extension and/or Conversion)
Job Description
- Ideally looking for someone with recent lab experience with Abbott Transfusion Medicine or ADD, but open to others with quality experience. Top Requires; Design verification experience, protocol reviews and approvals, Excel (pivot tables are very helpful for this type of data analysis), design output/transfer, and design validation. Bachelors Degree required with 1-3 years experience / degree in a scientific discipline (biology, biochem, some sort of engineering) would be helpful.
- Analyze quality standards for components, materials or services. Apply measures, sampling methods, testing methodology and other procedures that ensure that quality standards are met.
- Design/Change Control - Responsibilities include participating in the development & review of all design input, risk management, design verification, design validation and design output/transfer related design change activity.
- Risk Management – Understands and applies basic Risk Management principles. Participates in the development and/or modification of Risk Management Files, FMEA’s, etc.
- Design Verification/Validation – Understands and applies basic Design Verification/Validation methods & principles. Participates in the development, modification and design review of Protocols, Data Summaries & Records.
- Documentation - Reviews documentation for accuracy, clarity, consistency, completeness and compliance for projects that vary from low to high complexity. Plans and performs assignments with a wide degree of difficulty.
- Quality System Compliance -Maintains awareness of standards that regulate our industry. Ensures compliance to site level policies and procedures by promptly reporting non-compliance issues to management within Division and Corporation as appropriate. Maintains vigilance to ensure adherence to Quality Policy and Quality system procedures by promptly reporting noncompliance issues to management.
- Quality Engineering – Participates on project teams and technical review boards. Coordinates quality decisions between different quality and engineering groups. Effectively navigates & facilitates project teams with respect to our processes and procedures ensuring the delivery of safe and effective products.
- Apply quality principles, analyzes quality records, prepares reports and recommends improvements.
- Conduct inspection, verification and validation of components or materials used in development processes.
- Document quality issues and performance measures for management review.
- Bachelor’s Degree Required
- Knowledgeable of FDA, Quality System Regulations (QSR), Medical Device Directive, ISO guidelines and 21 CFR Part 11
