Department: Azzur Consulting LLC
Azzur Group is in search of a Top Notch Quality Assurance Specialist to join our growing mid-West team. The person in this role will be responsible for assisting with QA Validation and reviewing and approving qualification of new systems. The QA resource will also review/approve vendor executed FAT/SAT documentation and lead the resolution of validation deviation closures.
Essential Duties and Responsibilities:
- Writes procedures, investigations, protocols, reports, change controls, etc. to support the Maintenance and Engineering, Validation, Quality, and Regulatory departments. Documents may be reviewed by senior or above consultants.
- Generates validation life cycle documentation (FAT, SAT, IOQ, PQ) for cleaning, sterilization, shipping, and processes validation and facilities, utilities, systems, equipment qualification/requalification.
- Writes and revises a variety of Installation, Operation and Performance qualification/verification related documents, including any of all of the following: SOPs, validation/verification master plans, guidelines and execution plans, automation test plans, engineering design reviews, commissioning, qualification or other technical documents, user requirement specifications (URS), functional requirement specifications (FRS), detailed design specifications, factory acceptance test documents (FAT), and/or commissioning test procedures.
- Responsible for writing investigations, deviations, CAPAs and Change Controls with client input, and senior consultant or above supervision.
- Develops Validation Plans for small to medium size validation projects, qualification of equipment, facilities, utilities, as well as cleaning, sterilization, and manufacturing process validation.
Qualifications and Requirements:
- Bachelors Degree in engineering, science, or equivalent experience required. Masters Degree in engineering, science, or equivalent technical degree is a plus.
- 2-5 years experience in validation services in a regulated, manufacturing environment within the biotechnology or pharmaceutical industry required.
- At Least 1 year of Quality Assurance in validation.
- Experience in executing protocols including systems such as Process Validation, utilities, manufacturing equipment and basic knowledge of laboratory validation.
- Strong knowledge of FDA and cGMP regulations, documentation practices, and project management skills preferred.
- Ability to read and interpret Piping and Instrument Diagrams (P&IDs), and electrical diagrams.
- Ability to interpret and carry out instructions furnished in written, oral, diagram, mathematical, or schedule form.
- Experience with temperature mapping and validation.
- Proficient in Microsoft Word, Excel, and PowerPoint
- Customer service/client relations
- Communication proficiency
- Attention to detail
- Can work productively independently with minor supervision
- Self-motivated, flexible, dependable and available
- Excellent organizational and time management skills
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 5 core values; Integrity, Putting Others First, Having the Courage to Take Action, Taking Personal Responsibility and Having 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.