Quality Assurance Specialist(Consultant)

Azzur Group Waltham , MA 02451

Posted 3 weeks ago

About Azzur:

Our employees are fueled by an entrepreneurial spirit and the desire to make a difference in the lives of our customers, coworkers and our partners. If youre ready to put in the work, take personal responsibility and test the limits of whats possible, were ready to provide the reward.

Do What You Love

At Azzur, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.

Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers.

Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzurs core values:

Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!

Ideal Qualities:

Ideal candidates will exhibit, or have the willingness to develop, the following qualities:

  • Strategic thinker with strong analytical skills who can translate client needs into actionable value-added activities, projects, and results
  • Understands the competitive landscape of the pharmaceutical and biotechnology industry
  • Understands worldwide regulations and phase appropriate applications
  • Willing to work hands on, assist with building client libraries, learn from mentors, and become a mentor for others.
  • Ensures activities are efficient, optimized, and client-centric.
  • Is highly motivated and organized
  • Able to produce results in a fast-paced, collaborative environment

Essential Duties and

Responsibilities:

Azzur personnel are expected to live up to our core values at all times and exhibit a high level of integrity and personal responsibility, especially when interacting with our valued clients. The following is a short list of the typical responsibilities and deliverables of any given project. The level of knowledge expected will be commensurate with level of incoming experience.

  • Review and approve batch records in support of product release
  • Participate or lead in deviation investigation review and approval
  • Approve CAPA and change control documents and activities
  • Author, review and approves GMP procedures and validation deliverables
  • Supports internal and external audits
  • Maintains third party vendor relationships
  • Advises in development of metrics and KPIs for approved QMS
  • Develops and maintains quality agreements
  • Carries out duties in compliance with all local, state, and federal regulations and guidelines including the FDA, EPA, and OSHA.
  • Complies with all client site policies and procedures.

Qualifications:

  • BS in Engineering, Science or equivalent technical degree.
  • Experience in an FDA regulated, manufacturing environment within the biotechnology or pharmaceutical industry.
  • Excellent written and verbal communication skills; excellent technical writing skills.
  • Strong interpersonal skills and the ability to work in a team environment.
  • Expert working knowledge of FDA and cGMP regulations and documentation practices.
  • Proficient in Microsoft Word, Excel, and PowerPoint.
  • Is able and open to working for multiple clients throughout the region

Azzur Group is an equal opportunity employer and promotes diverse culture, ethnicity, gender and age in our workplace. We believe that promoting diversity plays an important role in developing top quality talent, fostering greater innovation and creativity, and enhancing our relationships with customers and the communities in which we operate.

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Quality Assurance Specialist(Consultant)

Azzur Group