Senior Quality Assurance Representative

Biopharma Careers; Indianapolis (IN); On-site; USD 69,000 - 111,000; Full time

Benefits offered by this job

health insurance

paid time off (PTO)

retirement contributions

other perquisites

Job summary

Biopharma Careers in Indianapolis, Indiana is seeking a QA Sterility Assurance on-the-floor oversight specialist for daytime manufacturing activities. This role reviews documentation, conducts line clearances, and ensures cGMP compliance throughout the process.

You will monitor aseptic processes, provide SME guidance on aseptic gowning, document GMP observations, and report any violations. The position offers a 10:00–18:30 shift, on-site work, and a competitive salary range.

Qualifications

• Bachelor's degree in Biology, Chemistry, or Life Science with GMP pharma experience or 5+ years with HS diploma.
• Experience with Excel, Word, Access and SAP.
• GMP pharmaceutical industry experience is required or strong equivalent.

Responsibilities

• Reviews executed documentation and ensures steps are recorded at time of execution and GxP compliance.
• Performs line clearances and room releases for manufacturing use.
• Reviews logbooks to confirm activities are completed and documented.

Skills

GMP knowledge

Quality oversight

Aseptic technique

Education

Bachelor's degree in Biology, Chemistry, or Life Science

High School Diploma or GED

Tools

Microsoft Excel

Microsoft Word

Microsoft Access

SAP

Job description

Work Location

Indianapolis, Indiana

Shift

No

Department

LS-SC-UYEQS1 QA Sterility Assurance

Recruiter

Katherine Hall

This information is for internals only. Please do not share outside of the organization.

Your Role

This role provides day shift support as quality assurance on-the-floor oversight for manufacturing activities at the facility.

Responsibilities

• 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.

Monday - Friday 10am - 6:30pm.

Physical Attributes

• Lift and/or move up to 25 pounds.
• Wear appropriate Personal Protective Equipment.

Minimum Qualifications

• Bachelors Degree in Biology, Chemistry, or other Life Science Discipline and 2+ years of GMP pharmaceutical industry experience.
• High School Diploma or GED and 5+ years of GMP pharmaceutical industry experience.

Preferred Qualifications

• Experience with 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.

Pay Range for this position: $69,200 - $110,900 / year

The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses.

Benefits

• health insurance
• paid time off (PTO)
• retirement contributions
• other perquisites

Equal Employment Opportunity Statement

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.