Quality Assurance Auditor I

Cambrex•Charles City, IA

7h•Onsite

About The Position

QA Auditor I supports the Quality Assurance department by performing routine internal audits, reviewing quality systems, and assisting with compliance activities to ensure adherence to GMP, regulatory requirements, and company policies.

Requirements

BS in Chemistry or a related field or equivalent industry relevant experience.
3 or more years of experience in manufacturing environment, preferably pharmaceuticals
Strong oral and written communication skills
Proficient in windows based environment including word processing, spreadsheet and database programs

Nice To Haves

Classes or education in Chemistry, Mathematics, Engineering, and computer software beneficial
Working knowledge of current good manufacturing practices and ICH Q7 and 21 CFR part 210 and 211 will be highly beneficial and preferred

Responsibilities

In Process/Finished Goods (FG) Analytical Record (AR) and Batch Record (BR) - Review
SAP transactions
Out Of Specification, Deviation, Investigation support and review utilizing TrackWise
CAPA initiation and review
Raw Material (RM) Analytical Record - Review & Approval
Operations Notebook Issuance
Participate in quarterly internal cGMP audits
Rotational coverage as an after hour QA resource
Issuance & Approval Inspect and approve repackaging records
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.