Department: Azzur San Diego, LLC
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.
Essential Duties and Responsibilities
- The primary responsibility for this role is to review executed batch records and release lots for clinical trials.
- Additional responsibilities may include:
- Provide oversight for all daily operations within QA, Validation, and documentation groups.
- Inventory log and batch record review (contract manufactured product) and disposition of clinical trial material
- Track and trend deviations, CAPAs, and out of specification/tolerance reports
- Assist with audit prep including planning internal audits and tracking quality action items to closure
- Supplier evaluation and oversight
- GMP documentation generation, revision, updates, and review
- Validation oversight including updating the VMP, managing validation contractors, URS, IQ, OQ, PQ generation and approvals
- Ensure site is working within state of cGMP compliance
- Maintain training, development, and support for all personnel working within cGMP functions
- BS in life sciences or equivalent
- 7-10 years experience within a pharmaceutical or biotechnology company (or MS with 5-7 years experience)
- 3 years supervisory experience
- Strong working knowledge of FDA and cGMP regulations and documentation practices.
- Excellent written and verbal communication and technical writing skills.
- Proficient in Microsoft Office Suite and able to learn new computer applications.
- Demonstrated experience managing others as well as fostering a team focused approach. The ideal candidate shall excel in the areas of communication, leadership, client loyalty, initiative and business integrity.
- Must be results oriented with several years of hands-on validation and QA management experience, familiar with industry concepts, practices and procedures in a cGMP environment
- Experience in the areas of design documentation (URS, FS, DS and other engineering specifications) Validation (IQ, OQ, PQ, PV, CV, CSV, etc.), and Quality Systems (Change Control, Non-Conformances, Requalification, etc.) is preferred
- Must have hands-on experience with batch record review and lot release.
Perks of Working at Azzur
- Medical, Dental and Vision
- Competitive 401K plan
- Volunteer Paid Time Off
- Flexible Paid Vacation Time
- Employee Recognition Program
- Diversity and Inclusion Initiatives
- Training and Mentorship Opportunities
Find us on social media
Instagram for our California regions: Azzur_LA, Azzur_SD and Azzur_SF
View our culture video in Youtube: https://www.youtube.com/watch?v=GPNjmsDu0LYAzzur Group is an equal opportunity employer and promotes diverse cultures, ethnicities, gender, and ages 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.