Quality Assurance Operations Lead

Cambrex•Charles City, IA

3d•Onsite

About The Position

The QA Operations Lead will work to develop and maintain quality systems that support the daily manufacturing operations to meet product and process quality metrics. They will act as an ambassador for World Class Manufacturing by working closely with operations team members, team leaders, technical support specialists and business unit leaders.

Requirements

Working knowledge of quality systems, cGMP, FDA requirements and industry standards
Strong critical thinking skills
Strong interpersonal and leadership skills, including initiative and strong work ethic.
Experience at a commercial manufacturing facility for pharmaceuticals is strongly preferred.
BS in sciences (preferably Chemical Engineer, Chemistry or Biology)
Minimum 4 years Quality Assurance Experience

Responsibilities

Complete area inspections prior to solids charging to vessels or heel removal from filters/dryers.
Perform equipment cleaning verification.
Participate in line clearances for product packaging.
Serve as plant floor support during normal processes. Conduct internal audits – floor type walk throughs – with Superintendents/Production Supervisors/Operators on a routine basis.
Provide training on cGMPs and Quality Systems on a regular basis and as need is presented.
Act as an ambassador for World Class Manufacturing by working closely with operations team members, team leaders, technical support specialists and business unit leaders.
Assessment and approval of deviations, including risk/impact assessments.
Correct/Preventative Action (CAPA) plans.
Complete investigations of Out-of-Specification/Out-of-Trend (OOS/OOT) results and other nonconformances.
Monitor and trend Quality Systems.
Review of production records.
Review of in-process and release testing.
Disposition of product, in-process and raw materials.
All employees are required to adhere to DEA, EPA, FDA and cGMP regulations as they relate to the operation of the Company; and to adhere to all company safety rules and procedures. All employees are expected to report to work regularly and promptly. Other duties relating to departmental mission, not specifically detailed in this section may be assigned.