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Cambrex High Point Quality Assurance Auditor in Charles City, Iowa

 

At Cambrex, it’s our people that set us apart. We work locally and have an impact globally. We’re committed to attracting, nurturing and retaining a passionate and talented team of experts in our fast paced and growing company. You will be valued and recognized. We offer an exceptional benefits package including medical, dental, vision, Life, LTD, generous vacation in your first year, sick time, and retirement savings!Cambrex is the small molecule company that provides drug substance, drug product and analytical services across the entire drug lifecycle. Known for our scientific and manufacturing excellence and customer focus, we offer a range of career opportunities across our global network of locations. As a team, we share one goal – to improve the quality of life for our customers’ patients across the world.

Responsibilities

Accountabilities and Responsibilities:

  • In Process/Finished Goods (FG) Analytical Record (AR) and Batch Record (BR) - Review & Approval

  • SAP transactions including material determination

  • Out Of Specification, Deviation, Investigation review and approvals utilizing TrackWise

  • Issuance & Approval Inspect and approve repackaging records

  • Critical Supplier Audits

  • Raw Material (RM) Analytical Record - Review & Approval

  • Laboratory and Operations Notebook Issuance

  • Quality Service Provider (QSP) Audits

  • Customer Internal/External Contact

  • Method Validation Reports, Analytical Development , Method Development - Review & Approval

  • Design and issue cGMP training materials and assessment tests

  • Participate in or lead quarterly internal cGMP audits.

  • Rotational coverage as an after hour QA resource

  • Back up to QA Inspector for Raw Material Inspections and Sampling including WFI water samples

    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.

Qualifications

  • BS in Chemistry or a related field or equivalent industry relevant experience. Classes or education in Chemistry, Mathematics and computer software beneficial

  • 3 or more years of experience in manufacturing environment, preferably pharmaceuticals

  • Working knowledge of current good manufacturing practices and ICH Q7 and 21 CFR part 210 and 211 will be highly beneficial and preferred

  • Strong oral and written communication skills

  • Proficient in windows based environment including work processing, spreadsheet and database programs

    Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status. (https://careers-cambrex.icims.com/jobs/1907/quality-assurance-auditor/job?mode=apply&apply=yes&in_iframe=1&hashed=-336240429)

Job LocationUS-IA-Charles City

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