Dieses Stellenangebot ist nicht mehr verfügbar
Senior QA Associate
K V K Tech
- Newtown, Ohio, United States
- Newtown, Ohio, United States
Über
The Senior QA Associate will serve as a key Quality Systems subject matter expert (SME), supporting multiple core elements of the site Quality Management System (QMS), including deviations, investigations, CAPAs, change controls, complaints, document control, and quality event trending. This role acts as a cross‑functional QA partner to Manufacturing, Packaging, QC, and Engineering, ensuring that all quality records are accurate, compliant, and scientifically justified. The ideal candidate will be a strong technical writer with deep QMS experience, capable of leading complex investigations, supporting audits and inspections, and driving continuous improvement across oral solid dosage operations.
Responsibilities
Review, approve, and manage deviations, investigations, CAPAs, change controls, and complaint records to ensure compliance with cGMP and data integrity expectations.
Conduct structured root‑cause analyses and develop scientifically justified corrective and preventive actions.
Author, revise, and review controlled documents, including SOPs, batch records, protocols, reports, and risk assessments.
Perform trend analysis of key quality metrics to identify systemic issues and support continuous improvement initiatives.
Provide QA support during internal audits, customer audits, and FDA inspections by preparing documentation and offering subject‑matter expertise.
Collaborate across operations to resolve documentation issues and ensure compliant execution of quality‑related activities.
Support training efforts by assisting in the development and communication of investigation‑writing and QMS best practices.
Qualifications
Bachelor’s degree in a scientific discipline such as Chemistry, Biology, Pharmaceutical Sciences, or Engineering.
5–8 years of pharmaceutical QA experience, preferably within oral solid dosage manufacturing.
Strong expertise in deviation investigations, CAPA management, change controls, and technical documentation.
Advanced knowledge of cGMP, data integrity principles, and ICH guidelines.
Proficiency with electronic QMS platforms (such as MasterControl, TrackWise, or Veeva) and strong analytical and communication skills.
Benefits
401(k) with company match
Health, vision, and dental insurance
Childcare expense reimbursement
Tuition reimbursement
Annual bonus eligibility
Annual merit increases
Paid Time Off and flexible holidays
KVK Tech is an affirmative action/equal opportunity employer and does not discriminate in hiring or employment on the basis of age, sex, race, color, religion, national origin, gender identity, veteran status, sexual orientation or any other protected status.
We encourage you to apply if you feel that you are a match! We look forward to hearing from you.
Apply for this position
Additional Information
Seniority level: Mid‑Senior level
Employment type: Full‑time
Job function: Quality Assurance
Industry: Pharmaceutical Manufacturing
#J-18808-Ljbffr
Sprachkenntnisse
- English
Hinweis für Nutzer
Dieses Stellenangebot wurde von einem unserer Partner veröffentlicht. Sie können das Originalangebot einsehen hier.