Quality Assurance Engineer

Cambrex; Charles City (IA); On-site; USD 65,000 - 95,000; Full time

Benefits offered by this job

Health insurance

Life insurance

Retirement planning

Job summary

Cambrex in Charles City, IA is seeking a Quality Assurance Engineer to serve as the liaison between our clients and the site, handling regulatory documentation requests and acting as a technical reviewer for stability, analytical methods, and batch records.

You will review customer specifications, support regulatory submissions, coordinate CEP/EDMF filings, and contribute to annual product quality reviews while ensuring compliance with DEA, EPA, FDA and cGMP.

Qualifications

• Must communicate in English, both written and spoken.
• Demonstrated critical thinking and problem-solving skills.
• Strong interpersonal and leadership abilities.

Responsibilities

• Serve as QA liaison to supply data for regulatory needs.
• Review customer specifications and stability data for compliance.
• Coordinate CEP, EDMF/MAA filings and customer inquiries.
• Review change controls for regulatory impact and compliance.
• Prepare and write Annual Product Quality Reviews.

Skills

Written & verbal comms

Critical thinking

Interpersonal leadership

Education

BS or BA

Job description

Company Information

You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services.

With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs.

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

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 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

The Quality Assurance Engineer is responsible for being the liaison between our generic clients and Charles City with regards to request for documentation to support their regulatory needs. This position also is a technical reviewer for internal projects such as stability protocols and reports, analytical method protocols and reports as well as managing customer complaints.

Responsibilities

• Key Quality Assurance customer support person to answer, address and/or compile relevant data to support Cambrex Charles City, Inc. products through customer requests through, but not limited to:Review of customers specification,Stability Data,Providing Standard statements of compliance
• Review of companies technical documents
• Serve as a liaison with new and existing customers concerning regulatory filings (i.e. coordinating issuance of CEPs, Letters of Authorization, coordinate filings of EDMF/CDMF with MAA, coordinate responses to customer inquiries).
• Review of various change controls for compliance to commitments made in Regulatory Submissions or requirements and complete assessments of regulatory impact.
• Review of data/records received from R&D, manufacturing, analytical, supply chain and Quality Assurance departments for corresponding with customers for regulatory support.
• Compile and author Annual Product Quality Reviews
• 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/Skills

• Ability to maintain written and oral communication in English required.
• Strong critical thinking skills
• Strong interpersonal and leadership skills, including initiative and strong work ethic.

Education, Experience & Licensing Requirements

• BS or BA
• 3-5 years of relevant experience preferably in a cGMP environment
• Experience at a commercial manufacturing facility for pharmaceuticals is strongly preferred.

Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration.

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.