Quality Assurance Operations Lead

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

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.

The QA Operations Lead will work to develop and maintain quality systems that support the daily manufacturing operations to meet product and process quality metrics. They will act as an ambassador for World Class Manufacturing by working closely with operations team members, team leaders, technical support specialists and business unit leaders.

Accountabilities and Responsibilities:

• Complete area inspections prior to solids charging to vessels or heel removal from filters/dryers.
• Perform equipment cleaning verification.
• Participate in line clearances for product packaging.
• Serve as plant floor support during normal processes. Conduct internal audits – floor type walk throughs – with Superintendents/Production Supervisors/Operators on a routine basis.
• Provide training on cGMPs and Quality Systems on a regular basis and as need is presented.
• Act as an ambassador for World Class Manufacturing by working closely with operations team members, team leaders, technical support specialists and business unit leaders.
• Responsibilities for Quality Systems administration and compliance support may include but are not limited to:
• Assessment and approval of deviations, including risk/impact assessments.
• Correct/Preventative Action (CAPA) plans.
• Complete investigations of Out-of-Specification/Out-of-Trend (OOS/OOT) results and other nonconformances.
• Monitor and trend Quality Systems.
• Responsibilities for Lot Release may include but are not limited to:
• Review of production records.
• Review of in-process and release testing.
• Disposition of product, in-process and raw materials.
• 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.

• Working knowledge of quality systems, cGMP, FDA requirements and industry standards
• Strong critical thinking skills
• Strong interpersonal and leadership skills, including initiative and strong work ethic.
• Experience at a commercial manufacturing facility for pharmaceuticals is strongly preferred.

• BS in sciences (preferably Chemical Engineer, Chemistry or Biology)
• Minimum 4 years Quality Assurance Experience

Cambrex is an Equal Opportunity / Affir

Cambrex Charles City offers an extraordinary opportunity, a competitive salary, and an exceptional benefits package including medical, dental, vision care and prescription, life, LTD, STD; 401(k) with employer match; tuition reimbursement; and the ‘Arthur I. Mendolia Scholarship Program.’ Relocation assistance will be offered for this position.

#LI-RD1

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 / Affir