Quality Assurance Spec 3

Job Title: Quality Assurance Spec 3
Location: Columbus, NE- Onsite
Duration: 7 Months+ (Possible Extension)

Shift: 1st Shift
 
Job Description:
Must Haves:

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

• 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.

• Investigation, prioritization, and timely response for customer complaints.
• Assess the complaint vs. established quality criteria. Determine the investigation path (valid vs. information).
• Effectively communicate findings thru technically written, data focused reports.
• Thoroughly investigate the non-conformance, driving to a root cause and robust corrective and preventative actions.
• Review batch records, change control, validation, Quality Notification trends, and other data sources as required as part of the investigation process.
• Work with the other Customer Quality Specialists to ensure all complaints are being investigated and timelines for the investigation are consistently met.
• Other duties as required to support the needs of the business.

• Required : HSD/GED
• Preferred : BA/BS – Engineering or another relevant field

• 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”