We are seeking highly motivated individuals that have the desire to learn, are able to adapt to
the ever-changing life sciences field and are flexible to work on various projects throughout the
Southern California region all while exuding Azzur’s core values: Put Others First, Courage to
Take Action, Take Personal Responsibility and Have Fun!
Essential Duties And Responsibilities
Write, revise, and review documents including forms, SOPs, BOMs, master batch records, etc.
Route documents through the client Ensure documents are reviewed and approved and approval process, following up with reviewers and approvers as necessary.
Assist with the close out of CAPA’s and Quality Events through the execution of treatment plans (TPs).
Write, revise, and review documents including master batch records, BOMs, SOPs, etc.
Maintain standardized templates and modules used in the generation of technical documents.
Work with multiple departments including Engineering, Validation and Quality Assurance.
Qualifications
BS in Engineering, Science or equivalent technical degree.
1-3+ years’ experience in a GxP 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 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.
Seniority level
Entry level
Employment type
Full-time
Job function
Marketing, Public Relations, and Writing/Editing
Industries
Pharmaceutical Manufacturing
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