QA Archivist

Azzur personnel are expected to always live up to our core values 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.

Key Responsibilities:

• Coordinate the archival, inventory, and shipping of document backlog in QA Archive room.
• Assisting in developing compliant and streamlined processes to support company’s record retention and archival program, including migration processes from paper-based to electronic systems.
• Helping to support building a robust physical document submission and retrieval process.
• Support the development and maintenance of the tracking system for the status and location of physical GxP documents.
• Assisting in additional Quality Assurance initiatives as assigned and/or applicable.

Qualifications:

• Bachelor’s degree with 5+ years of project and program management experience, preferably in the Medical Device industry.
• Knowledgeable medical device standards such as ISO 13485 and CFR 830.30. Follow policies, processes, and procedures in the quality system.
• Experienced in all facets of project management methodology including the generation and maintenance of Gant Charts.
• Excellent communication skills in facilitating cross functional team meetings and communicating status updates to stakeholders.
• Expert in MS Project or equivalent scheduling and tracking programs.
• Proven track record of successful collaboration and leadership to cross-functional teams to advance complex projects to completion.
• Excellent organizational, leadership, teamwork, written and verbal communication skills together with demonstrated ability to work in a highly matrixed team environment with enthusiasm and a proactive, positive attitude.
• Proven problem-solving, analytical, and critical thinking skills.
• Experience with risk analysis methodologies and thorough understanding of data analytics

 Requirements:

• 2+ years of document control experience supporting documentation programs and systems in pharmaceutical or biopharmaceutical industries.
• Strong knowledge GxP regulations, quality systems (Document Control, Training) and Records Management
• Must have excellent attention to detail, project, and time management skills as well as the ability to manage multiple priorities with aggressive timelines.
• Experience with FDA inspections and inspection readiness activities is preferred.
• Ability to lift to 20 pounds.

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 projects/results.
• Understands the competitive landscape of the medical device, pharmaceutical, and biotechnology industry.
• Willing to work hands on, assist with building client libraries, learn from a mentor, and become a mentor for others.
• Understands worldwide regulations and phase appropriate applications.
  Draws insights from projects and supplemental research to help drive new and existing growth. 
• Ensures activities are efficient, optimized, and client centric. 
• Highly motivated and organized, solutions-oriented leader.
• Curious and adaptable - can transform knowledge into actionable activities.

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 you’re ready to put in the work, take personal responsibility and test the limits of what’s possible, we’re ready to provide the reward.

Do What You Love

At Azzur Group, it is our purpose to foster a culture that attracts and enables individuals with unique abilities and passions to reach both their life and career goals.  We take crucial steps to ensure that each employee is fulfilled both in and out of the office. In addition to our purpose, we have a set of core values that we live and breathe each day. Every benefit offered here at Azzur is designed to uphold our 4 core values; Put Others First, Have the Courage to Take Action, Take Personal Responsibility and Have Fun.  It is our mission to serve our communities, build positive and established relationships, create a healthy and fun work environment, ensure each employee and their families are healthy and thriving, grow each employee professionally with one of our customized training programs and keep a clear and open line of communication.

We are an equal opportunity employer and promote 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. If philanthropy, long lasting relationships, a clear career path forward and a positive, transparent, and fun company culture are something you are looking for in your next role, Azzur is the place for you.

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