Specialist QA

Xtalks; Carolina (NC); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a Specialist QA to support QA programs with minimal supervision. The role involves reviewing and approving product MPs, batch records, change controls, CAPA, and site audits, while collaborating with Manufacturing, Engineering, and Process Development to uphold GMP and GDP standards.

Bilingual English/Spanish is preferred. Strong project management and data trending skills are valued, with extended hours and occasional weekends possible.

Qualifications

• Experience with GMP manufacturing and QA review of change controls, deviations, CAPAs, protocols, reports.
• Experience supporting packaging/inspection operations and regulatory interactions.
• Bilingual English/Spanish communication preferred.

Responsibilities

• Review and approve product MPs.
• Approve validation protocols/reports for manufacturing processes.
• Lead site audits and investigations.
• Own site quality program procedures.
• Review and approve risk assessments, CAPAs, and change controls.
• Provide lot disposition and authorize lots for shipment.

Skills

GMP knowledge

QA review

Project management

Cross-functional collaboration

Bilingual English/Spanish

Strong communication

Data trending

Education

Doctorate or Masters + related exp

Bachelors + related exp

Associates + related exp

High school/GED + 10 years

Tools

Electronic quality systems

Job description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

Specialist QA

Description

Perform one or more of the following duties and responsibilities in support of the Quality Assurance program under minimal supervision.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Request Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Lead site audits.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• Review Risk Assessments.
• Support Automation activities.
• Support facilities and environmental programs.
• Review and approve Work Orders.
• Review and approve EMS/BMS alarms.
• Approve NC investigations and CAPA records.
• Approve change controls.
• Provide lot disposition and authorize lots for shipment.

Qualifications

• Doctorate or Masters + 2 years of directly related experience or Bachelors + 4 years of directly related experience or Associates + 8 years of directly related experience or High school/GED + 10 years of directly related experience.
• Preferred candidates will have GMP manufacturing experience in Quality Assurance, including review and approval of change controls, deviations, CAPAs, protocols, reports, and procedures. Experience supporting packaging/inspection operations, strong knowledge of GDP and electronic quality systems, and the ability to collaborate effectively with Manufacturing, Engineering, and Process Development are highly desired. Bilingual English/Spanish communication skills are preferred.
• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Initiate and lead cross functional teams.
• Enhanced skills in leading, influencing and negotiating.
• Strong knowledge in area of expertise.
• Collaborate and coordinate with higher level outside resources.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
• Demonstrate ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet application skills.
• Strong communication (both written and oral), facilitation and presentation skills.
• Strong skill in working independently and to effectively interact with various levels.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.
• Demonstrate the Values/Leadership Practices.
• Available to work extended hours, possibility of weekends and holidays.