Department: Azzur of NE, LLC
Do What You Love
Our purpose and passion is to “Foster a culture that attracts and enables individuals with unique abilities and passions to reach their life and career goals.” We look for talented individuals who take pride in the work they do. We fuel employee growth by encouraging our employees to focus on doing what they love and what they do best.
Qualified candidate must have a desire to learn, apply, engage and adapt while simultaneously exuding Azzur’s Core Values: Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!
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 - has the ability to transform knowledge into actionable activities
- 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.
- Development and review of technical documentation including:
-Standard Operating Procedures
-User Requirements and Design Specifications
- Commissioning and Qualification Protocols
- Execution of validation test procedures
- CAPA and Change Management
- Thermal mapping of Autoclaves and SIP processes
- Technical report writing
- Data Analysis
- P&ID walkdowns
- Performs/executes/validation/verification studies (FAT, SAT, CTP, IQ, OQ, PQ) for cleaning, sterilization, equipment, systems, utilities, and processes for qualification/verification and/or re-qualification/re-verification.
- Prepare and review SOPs and other documents for compliance and provide guidance and counsel to staff as needed.
- Evaluate processes, propose solutions resolve issues and communicate results to support project/task completion.
- Develop and complete deliverables related to QA activities as needed to ensure objectives are met.
- BS in Engineering, Science or equivalent technical degree.
- At least 5 years of experience of validation and/or Quality in a regulated, manufacturing environment within the biotechnology, pharmaceutical or medical device industry.
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.), and Process Excellence Methodologies (Six-Sigma, Lean, etc.).
- Excellent written and verbal communication skills; excellent technical writing skills.
- Strong communication, interpersonal skills and the ability to work in a team environment.
- Ability to work effectively in a fast paced multitasking environment.
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Proficient in Microsoft Word, Excel, PowerPoint.
- In-depth understanding of various FDA regulations/guidance including 21CFR Part 11
- Ability to travel to client sites throughout the New England region.