Sr. Quality Assurance Specialist for FLAMMA USA

Senior Quality Assurance Specialist

Job Description:

• Maintain and improve the site’s Quality Management System, including training, document control, and deviations.
• Oversee the site’s compliance with cGMPs, corporate policies, and procedures.
• Creation of controlled documentation, including SOPs.
• Provide key feedback on resolving compliance issues.
• Review and approval of change control, deviations, CAPAs, and LIRs.
• Owner of site training including scheduling, re-training, and training on revised documentation.
• Support and ensure compliance of the calibration/PM system for equipment.
• Review and approve documentation for the disposition of GMP components, raw materials, intermediates, and APIs.
• Review and approve master and executed batch records for GMP campaigns.
• Lead audits of the site including FDA and customer audits.
• Maintain and execute the internal audit program.

Qualifications:

• Knowledge of regulatory compliance including 21CFR Part 211
• Strong organizational skills and detail oriented
• Strong technical writing skills
• Ability to work independently to meet deadlines
• Bachelor’s Degree
• Experience working in a synthetic and/or analytical laboratory environment with a focus on small molecule pharmaceuticals preferred
• QA experience in the biotech, and/or pharmaceutical industry preferred
• Experience with OSHA regulations preferred
• Previous internal auditing responsibilities preferred

Responsibility and compensation:

In this hands-on position, you will have the exciting opportunity to contribute to the installation of the Quality Management System in Flamma’s new Malvern PA site.  You will report directly to the Head of Operations and will be a key team member in the organization with significant responsibilities.

The Flamma Group is a growing CDMO. You will join a growing company that has established a solid reputation worldwide. As part of our collaborative Malvern team, you will be able to enjoy a satisfying career as a Senior Quality Assurance Specialist. You will work directly with Flamma management located in Italy, France, and the USA as well as customers located in Europe and the USA.

Starting salary will be based on experience. This is an excellent opportunity for someone looking to be part of a ground floor opportunity as Flamma grows their presence in the USA.

ABOUT FLAMMA:

FLAMMA is a CDMO with Headquarters near Milan, Italy. As a fully integrated CDMO, we can leverage our 100% self-owned, self-managed facilities, in Italy, China, and USA to deliver a stable, reliable supply chain. We specialize in the cGMP manufacturing of APIs, NCEs, RSMs, & Advanced intermediates (NCEs and generics). We use our expertise in high value chiral materials (specifically amino acid related materials) to provide solutions to customers who not only have need for chiral materials but also clients who have other requirements with a various type of chemistries. In addition, we also manufacture specialty compounds and advanced intermediates for the nutraceutical and cosmetic industries. We also have a variety of niche generic products.

Job posted August 21, 2019