QA Operations Associate I

American Regent, Inc.; New Albany (OH); On-site; USD 55,000 - 75,000; Full time

Job summary

American Regent, Inc. in Ohio seeks a Quality Assurance Associate focused on ensuring GMP compliance across packaging lines and inspection rooms.

You will perform verifications, AQL inspections, and release of components and materials, while maintaining strict adherence to SOPs and regulatory requirements. The role requires the ability to work independently in a FDA-regulated environment, strong communication skills, and proficiency with Word and Excel.

Qualifications

• High School Diploma or GED required; Associates or Bachelor's degree preferred.
• Minimum 1 year in an FDA-regulated environment or similarly regulated area.
• Proficient in Word and Excel; strong organizational and communication skills.

Responsibilities

• Achieve and maintain packaging line and inspection room clearance qualification.
• Conduct accurate verifications and checks as well as accurate process inspections.
• Identify out of specification product, ensuring segregation and escalation as required.
• Ensure all work is performed and documented in accordance with SOPs and cGMP.
• Support product shipping activities and perform quality-related oversight and verifications.

Skills

GMP knowledge

cGMP

Documentation

Microsoft Excel

Team player

Education

High School Diploma

Associates or Bachelor's degree preferred

Tools

Microsoft Word

Microsoft Excel

Job description

Nature and ScopeThis position is responsible for ensuring the overall Quality in their assigned areas through the execution of site policies and procedures, programs and work instructions. Ensures all processes and products meet specifications and that products are produced in accordance with GMP requirements.Essential Duties and ResponsibilitiesNothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.Achieve and maintain packaging line and inspection room clearance qualificationConduct accurate verifications and checks as well as accurate process inspectionsConduct accurate packaging AQL inspectionsIdentify out of specification product, ensuring segregation and escalation, as requiredEnsure errors and omissions are resolved according to Standard Operating Procedure (SOP) requirementsEnsure all work is performed and documented in accordance with existing Company policies and procedures, as well as cGMP, health and safety requirements.Conduct component and raw material releaseConduct chart monitoring, ensuring escalation, as requiredSupport product shipping activities and perform quality related oversight and verificationsGenerate logbooks and sheets/labelsReview Bills of MaterialsBasic knowledge of cGMPs and supporting regulatory documentsAchieve and maintain clean side gown and sterile side gown qualificationsAchieve and maintain Class A qualificationPerform room, area and equipment clearances.Participate in Media Fill and maintain qualificationAble to perform tasks with minimal error rate.Perform any other tasks/duties as assigned by management.Education Requirements and QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.High School Diploma or GED equivalent required. Associates or Bachelor’s Degree preferred.Minimum 1 year work experience in a FDA regulated environment or similarly regulated area is preferred.Must be able to do work independently.Intermediate skills in Microsoft Word and Excel are required.Excellent organizational, interpersonal and communication skills (written and oral) required.Ability to take feedback constructively and function in a team oriented work environment.Ability to work overtime as needed. Physical Environment and RequirementsPhysically able to wear cleanroom/protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and Respirators are essential for the health and safety of employees.Specific vision requirements include 20/20 near vision (can be corrected with eyeglasses or contacts) and color vision.Employees must maintain a clean-shaven appearance each working shift to wear tight-fitting respirators properly.Employee must be able to occasionally lift and/or move up to 25 pounds.American Regent celebrates diversity and we are committed to creating an inclusive environment for all employees. We are an Equal Opportunity Employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability status, or protected veteran status.Applicants have rights under Federal Employment Laws.FMLA poster: https://www.dol.gov/whd/regs/compliance/posters/fmlaen.pdfKnow Your Rights: Know Your Rights: Workplace discrimination is illegal (eeoc.gov)Employee Polygraph Protection Act: https://www.dol.gov/whd/regs/compliance/posters/eppac.pdfAlert: We’re aware of individuals impersonating our staff to target job seekers. Please note:· All legitimate communication will come directly from a verified ARI recruiter either by phone or via an americanregent.com email address.· Our recruiting process includes multiple in person and/or video interviews and assessments.· If you are unsure about the legitimacy of a message, contact John Rossini at [e-mail] before responding.· We never request payment, bank information, or personal financial details during our offer process.Your security is important to us, and we encourage you to stay vigilant when job searching.American Regent Inc. endeavors to make https://careers.americanregent.com/ accessible to any and all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please email [e-mail].