- 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
- 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
- HS Diploma or equivalent. Some experience or educational courses in chemistry, biology or related scientific field desired.
- Experience of 1 to 2 years in a quality and/or manufacturing industry setting preferred.
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Assistant QA Scientist - High Point, United States - Cambrex Corporation
Description
Job Description
Company InformationYou Matter to Cambrex.
Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance, drug product, and analytical services across the entire drug lifecycle. With more than 40 years of experience and a growing team of over 2,400 professionals servicing global clients, Cambrex is a trusted partner in branded and generic markets for API and dosage form development and manufacturing.
Your Work Matters.
At Cambrex, we strive to build a culture where all colleagues have the opportunity to:
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.
Job OverviewResponsibilities
#LI-RD1
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.
