Quality Assurance Specialist - GMP LIMS Empower EL

Description Home Search Jobs Job Description Quality Assurance Specialist - GMP LIMS Empower ELContract: Cincinnati, Ohio, USSalary Range: 28.00 - 33.00 | Per HourJob Code: 367855End Date: 2026-04-02 Days Left: 14 days, 3 hours leftApplyTo Discuss more about this job opportunity, please reach out to Deepak Arya LinkedIn URL /in/deepak-arya-8a79aa22a/ , email your updated resume at Email deepak.arya@ . Thank you!Pay Range: $28 to $33 an hourIndustry: PharmaceuticalWork Type: OnsiteContract Duration: 06 Months (Possibility of Extension)Description:The Quality Assurance Specialist is responsible for providing quality assurance and compliance support to Quality Control (QC) laboratory operations. This role ensures that laboratory processes, documentation, instrumentation, and systems operate in alignment with GMP and regulatory requirements. The position supports compliance oversight, equipment lifecycle management, documentation review, and quality system improvements. The role works cross-functionally to maintain inspection readiness and drive continuous improvement within the QC lab environment.Must Haves: 6+ years of GMP laboratory experience Strong documentation review experience within QC or QA Experience with Empower Experience with LIMS Experience with Electronic Lab Notebook (ELN) systems 4+ years of quality assurance, quality oversight, or related experience Working knowledge of GMP compliance and regulatory requirements Experience with laboratory instrumentation qualification, calibration, and validation Bachelor's degree in Chemistry, Biology, Microbiology, Pharmacy, Engineering, or related scientific field Day to Day: Serve as compliance specialist for the QC lab and perform routine compliance assessments. Communicate compliance risks and findings to laboratory leadership on a regular basis. Ensure completion of periodic laboratory inspection readiness and data review checklists. Coordinate and support internal and external laboratory audits. Review compendial changes, assess impact, and assign verification testing as required. Coordinate instrument calibration activities including scheduling, approval, and impact assessment. Review and approve instrument-related investigations and documentation. Support procurement, installation, qualification, and lifecycle management of laboratory equipment. Review QC documents such as methods, qualification protocols, and calibration documentation for regulatory compliance. Lead or support quality documentation projects related to calibration and validation. Participate in validation review activities for equipment qualification. Support quality system improvements and cross-functional process enhancements. Assist in development and delivery of training materials for laboratory compliance processes. Plusses: Experience with change management processes Experience leading cross-functional teams Knowledge of product testing and test method requirements Experience supporting pharmaceutical, biologics, or medical device environments Strong written and verbal communication skills Experience with equipment lifecycle management systems Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)Job Requirement GMP LIMS Empower QA Reach Out to a Recruiter Recruiter Email PhoneDeepak Arya deepak.arya@ Apply Now

Created: 2026-04-02