Quality Assurance Spec 3

Quality Assurance Spec 3
Columbus, NE- Onsite
Duration: 7 Months+
Shift: 1st Shift

Must Haves:
Statistical analysis skills
Analytical skills
Technical writing skills
Communication skills
Problem solving skills
Quality system knowledge (cGMPs and ISO)

Proficient preferred :
Root cause investigation skills
Units, and WW Quality Units to support resolution of customer quality issues. Use investigation results to continually assess the adequacy of process and systems, issuing corrective actions as required to maintain an effective quality system. Supports the quality of material and product by verifying standard operating procedures (SOP s), product specifications and Good Manufacturing Practices (GMP). Ensures compliance with Client quality systems, policies, procedures, and best practices, and all local, state, federal and Client safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Ability to read and write and converse in English.

Responsibilities include but are not limited to:
1. Investigation, prioritization, and timely response for customer complaints.
2. Assess the complaint vs. established quality criteria. Determine the investigation path (valid vs. information).
3. Effectively communicate findings thru technically written, data focused reports.
4. Thoroughly investigate the non-conformance, driving to a root cause and robust corrective and preventative actions.
5. Review batch records, change control, validation, Quality Notification trends, and other data sources as required as part of the investigation process.
6. Work with the other Customer Quality Specialists to ensure all complaints are being investigated and timelines for the investigation are consistently met.
7. Other duties as required to support the needs of the business.

This position does not supervise any associates at any level
Minimum Education :
Required : HSD/GED
Preferred : BA/BS Engineering or other relevant field

Minimum Experience :
1-3 years GMP experience
Pharmaceutical/medical device experience preferred
1 3 years experience with root cause investigation tools.
1-3 years working with within a team environment