Quality Compliance Consultant

Location: College Station, TX
Department: Azzur Austin, LLC

Job Description

Summary: 
The Quality Compliance Consultant leads the tracking, coordination, and closure of
Manufacturing CAPAs, change controls and deviations, and assists in supporting the timely release and
disposition of batches and other post-execution activities.

Essential Functions:

Compliance:
 Coordinate batch and formulation record review and corrections to executed records.
 Coordinates the initiation of new deviations.
 Leads deviation, CAPA, and change control closure for Manufacturing, including initiation
of New Product Introduction change controls.
 Leads Problem Analysis (PA) events.
 Leads After Action Reviews (AAR).
 Schedules and facilitates post manufacturing campaign lessons learned.
 Leads the completion of periodic reviews.
 Provides and maintains metrics around batch closure, including deviation, CAPA and
change control status.

Required Skills & Abilities:

Good oral and written communication skills, interpersonal and organizational skills.
 Practical understanding of equipment used in bioprocessing (downstream and/or
upstream).
 Proficient with Microsoft Office applications.
 Good self-discipline and attention to detail.
 Must have flexible work hours – must be willing to work outside of normally-scheduled
hours as necessary; including opportunities for alternative shift-hours and weekends as
required.
 Experience working in cleanroom environments.
 Must have good planning skills and must be willing to interface with and support team
members in many different roles and functions throughout the manufacturing facilities.

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.  Reasonable accommodations may be made to
enable individuals with disabilities to perform the essential functions.  While performing the duties of this
job, the employee is regularly required to:

Experience prolonged standing, some bending, stooping, pushing, pulling, reaching
above shoulders and stretching.
 Use hand-eye coordination and manual dexterity sufficient to operate a keyboard,
photocopier, telephone, calculator, and other office equipment.
 Lift up to 25 pounds frequently and up to 50 pounds, on occasion.
 Attendance is mandatory.

Qualifications:

Bachelor’s Degree with two (2) years related experience, preferably in biopharmaceutical
manufacturing (GLP or GMP) or Quality Assurance.
 Associate degree and four (4) years of related experience preferably in biopharmaceutical
manufacturing (GLP or GMP) or Quality Assurance.
 High School Diploma or GED and six (6) years’ experience preferably in biopharmaceutical
manufacturing (GLP or GMP) or Quality Assurance.

Preferred Qualifications:

Experience with cell culture and purification processes
 Experience authoring CAPAs, change controls, and deviations

Azzur Group is an equal opportunity employer and promotes a diverse culture 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.  All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status. 


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