Work Location: Indianapolis, Indiana Shift: No Department: LS-SC-POEQS Sterility Assurance Recruiter: Katherine Hall
This information is for internals only. Please do not share outside of the organization.
Your Role:
This role provides weekend shift (Friday - Sunday) support as the primary quality assurance on-the-floor oversight for manufacturing activities at the facility, with the availability to flex to weekday shifts for training activities. There are multiple QA floor support representatives supporting manufacturing so that manufacturing activities on each shift are covered.
Responsibilities include but are not limited to:
Reviews executed documentation to ensure steps are documented and verified at time of execution and that good documentation practices are being followed
Performs and documents line clearances and room release for manufacturing use
Reviews logbooks in manufacturing areas to ensure required activities are being completed and documented
Monitors the formulation and filling processes to ensure cGMP compliance
Provides aseptic core monitoring, acting as a SME for aseptic technique and providing reinforcement of aseptic practices to Manufacturing filling operators. Requires qualification in aseptic gowning and certification as an aseptic processing SME
Observers, reports, and documents operator cleaning and disinfection practices
Documents, reports, and trends observations stemming from Quality Oversight
Documents and reports to management GMP violations, unsafe conditions, or other unusual results or practices
Partners with manufacturing supervision to immediately address and develop plans of action for deficiencies observed in manufacturing operations or the manufacturing facilities. Deficiencies include any GMP violations, unsafe conditions, improper aseptic practices or other unusual results or practices
Escalates significant issues immediately to Quality Assurance management
Performs document revisions, deviation reviews, and processes change controls in existing Quality Systems
Provides training to operations personnel in areas such as FDA requirements, good documentation practices, contamination prevention, and housekeeping
Serves as a resource during investigations of deviations and unexpected events. This includes interviewing operators and providing first-hand accounts of operations observed
Physical Attributes:
Lift and/or move up to 25 pounds
Who You Are:
Minimum Qualifications:
Bachelors Degree in Biology, Chemistry, or other Life Science Discipline and 2+ years of GMP pharmaceutical industry experience
OR
High School Diploma or GED and 5+ years of GMP pharmaceutical industry experience
Preferred Qualifications:
Experience computer software applications including Microsoft Excel, Word, and Access
Experience with Quality Management computer systems and SAP
Experience with EU Annex 1 classified areas A, B, C, and D including acceptable aseptic behaviors, practices, and gowning
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, transgender status, marital status, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to their Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because they made a good faith report of discrimination.
