Senior Quality Assurance Representative

Lehigh Heavy Forge Corporation; Indianapolis (IN); On-site; USD 69,000 - 111,000; Full time

Benefits offered by this job

Health insurance

PTO

Retirement contributions

Perquisites

Job summary

Lehigh Heavy Forge Corporation in Indianapolis, IN, seeks a QA Sterility Assurance professional for on-the-floor oversight of manufacturing activities. The role emphasizes aseptic technique, GMP compliance, and thorough documentation in a day shift (10am–6:30pm), with responsibilities including line clearances and room release.

The candidate should hold a Life Science degree or equivalent GMP experience, and be proficient with Excel, Word, Access, and SAP.

Qualifications

• Bachelor's Degree in Biology, Chemistry, or Life Science with 2+ years GMP experience.
• Or High School Diploma with 5+ years GMP experience.
• Experience with Excel, Word, and Access.
• Experience with Quality Management systems and SAP.
• Experience with EU Annex 1 areas A, B, C, D including aseptic practices.

Responsibilities

• Reviews documentation to ensure steps are documented and verified at execution with GMP practices.
• Performs line clearances and room release for manufacturing use.
• Reviews logbooks to ensure activities are completed and documented.
• Monitors formulation and filling to ensure cGMP compliance.
• Provides aseptic core monitoring and acts as SME for aseptic technique and gowning.
• Observes and documents operator cleaning and disinfection practices.
• Documents observations and trends from Quality Oversight.
• Reports GMP violations or unsafe conditions to management.

Skills

GMP knowledge

Education

Bachelor's degree in Biology/ Chemistry/ Life Science

High School Diploma or GED with 5+ years GMP experience

Tools

SAP

Quality Management Systems

Microsoft Excel

Microsoft Word

Microsoft Access

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 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.
• Monday - Friday 10am - 6:30pm.

Physical Attributes:

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

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 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 offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites.

RSREMD

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.