Associate Quality Assurance Scientist

3 weeks ago

High Point, United States Cambrex High Point Full time

Company Information

You 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 2,000 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:

+ 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

Were 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 healthcare, life insurance, planning for retirement, 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

Perform daily QA activities to support GMP projects, GMP ordering, inspection of production/sample rooms, assist with material inventory/tracking, and other duties as notified by supervisor. Also provide nonGMP support for raw material control and batch record review/approval.

Responsibilities

+ Perform approval process for calibration program. Maintain controlled documents.

+ Perform initial review of nonGMP /GMP batch records along with supporting documentation as required for customers.

+ Perform final review and maintain signature approval of nonGMP/GMP batch records along with supporting documentation as required for customers.

+ Perform release of raw materials and intermediates.

+ Perform visual verification of glassware/equipment cleaning forms and maintain logbooks.

+ Perform approval process of logbooks in analytical/production areas.

+ Assist with management and issuance of logbook/notebook system.

+ Assist with development, writing, and placement of standard operating procedures.

+ Assist with shipping and inventory of materials.

Infrequent Functions:

+ Assist with training records.

+ Assist with basic training in regulatory areas.

+ Serve as a backup to Document Control Specialist.

+ Other duties as assigned and/or developed by your supervisor.

Qualifications/Skills

A minimum of 2 years of relevant background in GXP compliant pharmaceutical laboratory environment or related quality area. Ability to create and interpret SOPs. Ability to work with minimal supervision.

Education, Experience & Licensing Requirements

BS or MS in Chemistry (or closely related discipline) or relevant experience. A minimum of 2 years of relevant background in GXP compliant pharmaceutical laboratory environment or related quality area. Ability to create and interpret SOPs. Ability to work with minimal supervision.

Sedentary work, exerting up to 10 pounds of force occasionally, and/or a negligible amount of force to occasionally lift, carry, push, pull or otherwise move objects. The daily work is performed in the office as well as the manufacturing suites. Walking and standing are required. Use of steps or ladders in the manufacturing areas may be required.

Position also requires visual acuity, talking, computer typing

Knowledge of working safely with chemicals.

All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law.

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