Job Title: Quality Assurance Analyst II
The Quality Assurance (QA) Analyst III, under general direction, will be responsible for review and/or
approval of basic and technical documentation; Drafting and reviewing of internal Quality policies and
procedures; Assisting in and performing product related activities; Assisting in and performing Quality
audit functions; Identifying process and Quality System improvements; Acting as a QA liaison internally.
Review basic and technical documentation to include, but not limited to:
o Standard Operating Procedures
o Batch Production Records
o Commissioning, qualification and validation protocols and reports
o Deviation Reports
o Corrective Action/Preventive Action Plans
o Data Reports
o Drug Substance/Product Reports
Review internal Quality policies, procedures and reports
Review and/or approval of executed process records and laboratory data
Assist in and perform Quality audit functions to include, but not limited to:
o Audit of lab notebooks
o Audit of equipment logbooks
o Review of vendor, supplier, contract laboratory audit questionnaires
Identify process and Quality System improvements
Act as a QA liaison to internal Kalon Departments and Vendor/Contract Laboratory Quality Groups
Notify Senior Management of potential quality or regulatory issues that may affect product quality
or regulatory compliance
All other duties as needed.
Required Skills & Abilities:
Excellent written and oral communication skills
Excellent organizational, analytical, data review and report writing skills
Ability to set personal performance goals and provide input to departmental objectives
Ability to adapt to frequent and rapid changes in the work environment and allocate, adjust and optimize time accordingly
Ability to work independently and establish work priorities to meet targets and timelines
Proficient in Microsoft Office
All candidates will have a working knowledge of cGMP regulations for the production of drug, biologics or vaccine products
Working Conditions & Physical Requirements:
The physical demands described here are representative of those that must be met by an employee to
successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to:
Experience prolonged sitting, some bending, stooping and stretching.
Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
Vision correctable to 20/20
Ability to wear restrictive gowning for extended periods of time during periods of prolonged
Attendance is mandatory.
Associate’s or Bachelor’s degree in a related science concentration with, preferably 4-6 years of
experience in Quality supporting pharmaceutical or biotechnology products; with minimum at
years cGMP operating experience working in QC, QA, Manufacturing and/or Validation; or
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, we look for talented individuals who take pride in the work they do. We foster employee growth by encouraging our employees to focus on doing what they love and what they do best.Azzur is a GxP compliance and consulting organization dedicated to providing high quality, expertly backed, assistance that drives life science companies to success. We are seeking highly motivated and talented individuals to join our incredible team of skilled problem solvers. Qualified candidates must have a desire to learn, apply, engage, and adapt in the ever-changing healthcare field while simultaneously and organically exuding Azzur’s core values:
Put Others First, Courage to Take Action, Take Personal Responsibility and Have Fun!