QA Manager

Agawam, Massachusetts, United States Full-time

Position Title: QA Manager
Job Location(s): Agawam, MA 
Start Date: ASAP
Employment Type: Full-Time
Starting Salary Range: Competitive
Job Requisition #: 18095

Cambrex (www.Cambrex.com) is seeking a highly motivated, energetic, results-oriented individual to join our team of dedicated professionals focused on customer service and quality. We are currently accepting resumes.

SUMMARY:  The Quality Assurance Compliance Manager will assume responsibilities associated with managing the Quality Management System and release of data  at Avista Pharma in Agawam, MA.

 

MINIMUM REQUIREMENTS:  Quality Assurance Audit experience in a GMP environment.  Position requires a Bachelor's Degree or higher in a scientific discipline (preferred) and three to five years minimum experience in a regulated industry with Quality Assurance audit experience. Previous management experience preferred. Experience with EDMS and electronic QMS platforms preferred

 

RESPONSIBILITIES:

  • Oversee and develop Quality personnel
  • Ensuring that all vendors remain in a state of compliance to Avista’s quality systems.
  • Manage technical and Quality review of data, equipment and facility validations
  • Maintain both internal and external audit program. Manage the Approved vendor program.
  • Auditing: Host Client and Regulatory audits manage responses/resolution, and audit follow-up.
  • Perform Quality Risk assessments associated with the Internal Audit and Vendor Audit Program.
  • Support the company by communicating and resolving compliance issues and Customer facing meetings.
  • Communicate effectively with internal personnel, as well as external customers.
  • Build teamwork within department and all other company departments.
  • Represent department and the organization favorably and in accordance with established Company standards and associate attributes at all times.
  • Accept, complete and report on special assignments within the agreed upon timeframe
  • Other duties as assigned by management.

 

TECHNICAL SKILLS

  • Understanding of regulatory requirements related to GMP/GLP and ISO Requirements
  • Practices and Good Documentation Practices.
  • Ability to read, analyze and interpret quality regulations, professional journals, and technical procedures in order to improve the quality systems.
  • Ability to effectively review procedures, data, reports, and protocols for compliance to internal procedures and regulations.
  • Able to plan, prioritize, coordinate, and manage own work in a fast-paced environment. Able to work unsupervised, make moderate level decisions independently, and solve problems effectively and creatively.
  • Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems.
  • Understand and maintain confidential nature of customer, organization and employee information.
  • Able to develop and give oral presentations to small groups of individuals inside and outside the organization.
  • High level of proficiency with PC based software programs.

 

Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.