At Cambrex, we strive to build a culture where all colleagues have the opportunity to:

• engage in work that matters to our customers and the patients they serve
• learn new skills and enjoy new experiences in an engaging and safe environment
• strengthen connections with coworkers and the community

We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes medical, dental, vision, Life, LTD, retirement savings and more!

Your Future Matters.

Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today!

Job Overview

Responsibilities

• Perform QA review of manufacturing activities such as cleaning inspections, room clearance, and in-progress batch documentation.
• Perform review and approval of material release data packs and executed cleaning batch records.
• Manage material inventory and sample requests with completion of associated documentation.
• Review executed production batch records and associated documentation.
• Assist with shipping documentation and coordination of material pickup with shipping vendors.
• Act as a compliance resource to provide guidance and assistance towards resolution of simple to moderate deviations.
• Review and may approve quality system documents related to manufactured products.
• Serve as a backup to Document Control.
• Ensure compliance with company policies and SOPs as well as FDA and other applicable guidelines.
• Assist with maintaining company’s quality system.
• Support continuous improvement of quality systems; author new, revise existing and may review department procedures and/or forms
• Other duties as assigned.

Qualifications/Skills

• Proven ability to work independently with minimum supervision.
• Vendor management and/or audit experience
• Excellent problem solving skills to include ability to use prior experience and judgment to resolve simple to moderately complex issues

Education, Experience & Licensing Requirements

Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects. The daily work is divided between performing in an office setting and walking in/out of the production suites for inspections and samples. Walking and standing are required. Use of ladders and roof access may be required. Position also requires visual acuity, talking, computer typing.