Quality Engineer (QA0601)

Company Information



Take charge of your career and grow in new directions by exploring opportunities within a growing Life Sciences Company...


Cambrex Bio Science Baltimore, a Cambrex Corporation, is a rapidly growing biotech company, dedicated to providing superior contract biopharmaceutical manufacturing services in our state-of-the-art facilities (Baltimore, MD and Hopkinton, MA). Our core competency is the production and purification of a variety of therapeutic and diagnostic products for clients in clinical trials and for commercial production. Cambrex Corporation (NYSE: CBM), is a $522 million innovative, global service leader supplying products and services to the life sciences industry. Headquartered in East Rutherford, NJ, Cambrex employs over 1,900 people located throughout the U.S., Europe, and Asia


Cambrex Bio Science, located in Baltimore, MD is seeking a Quality Engineer who shares the values and principles that characterize who we are - and how we work. It's time to join our world-class team, if the following attributes reflect your desire to contribute:


Innovation -Cambrex employees have a strong desire to excel and apply their skills in innovative ways to meet the demands of an ever-changing business environment.



Experience - Cambrex employees provide knowledge-based solutions, are empowered to make appropriate decisions, and demonstrate a commitment to quality in everything they do.



Performance - Cambrex is an organization that appreciates and rewards, efficient, reliable performance, meets goals and objectives, and delivers the Cambrex promise to bring value to our customers and investors with uncompromising integrity and ethics.



Job Description

The Quality Engineer supports the Quality Groups (QA and Validation) by providing a technical resource in the areas of Biotech manufacturing and validation. Additionally, this position will be responsible for investigating, troubleshooting and securing appropriate resolutions to manufacturing and quality related issues. The Quality Engineer will also assume the responsibly for the monitoring and statistical analysis of manufacturing and quality trends



Job Responsibilities

Responsibilities include, but are not limited to:


Assume a primary role in investigating and resolving critical deviations / non-
conformances, and the associated CAPA items.

Provide technical expertise in the development and implementation of quality systems that support the manufacturing processes for compliance and continuous improvement.

Keep Department Head informed of any problems that are likely to have an impact on quality or GMP compliance.

Develop and implement required quality systems and procedures.

Provide technical assessment and validation review/approval for engineering and process changes.

Participate in the preparation and management of client audits and regulatory inspections.

Coordinate the collection and submission of manufacturing information to the Clients to fulfill annual review and reporting requirements.

Interact with Clients as a Quality representative during manufacturing, troubleshooting, and update activities.

Perform internal audits as well as vendor/supplier audits. Generate audit reports. Ensure noted deficiencies are addressed. For internal QA audits, determine where improvement in operation can be made.

Develop GMP and technical training materials. Provide employee training.

Participate in the project proposal process by providing accurate estimates of the resource requirements, and help drive the completion of those goals.

Other duties as assigned. REQUIREMENTS



Job Qualifications

BS/MS degree in Chemistry, Biochemistry or Engineering and 6 years of direct experience with a biotech manufacturing facility producing clinical or commercial products by microbial fermentation or cell culture or an equivalent combination of education and experience.

Ability to appropriately manage time and work effectively with little supervision both individually and as a team.

Experience in Design Control and Change Management.

Ability to direct others regarding work priorities and assist in ensuring their completion.

Excellent organizational skills and the ability to manage large quantities of documentation.

Require strong technical writing, verbal communication, interpersonal and problem solving skills.

Ability to analyze data for accuracy and correctly interpret results. Draw conclusions from data to generate a sound “scientific” report, and defend those conclusions during regulatory inspections.

Ability to evaluate and trend data through statistical analysis.

Demonstrated ability to solve problems and bring issues to quick resolution. Experience with conducting investigations and assigning appropriate CAPA is required.

Strong knowledge in GMPs, quality systems, and other FDA and EU regulatory requirements for drugs, biologics and devices.

Understanding of process development and technology transfer concepts

Proficient with Microsoft office suite.



Cambrex Bio Science offers a competitive salary and a comprehensive benefits package including medical (PPO), dental, vision, disability, life insurance and AD&D, in addition to tuition reimbursement, flexible spending accounts, a generous Paid Time Off package, and a matching 401(k) plan.


Please visit our web sites at www.cambrex.com for more exciting information about Cambrex Bio Science!


Equal Opportunity Employer M/F/D/V.

Thank you for your interest in Cambrex Corporation!


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