Specialist QA

ECHO Consulting Group Inc; Juncos (PR); On-site; USD 60,000 - 90,000; Full time

Benefits offered by this job

Competitive compensation package

Professional development

Job summary

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management.

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

Qualifications

• Experience reviewing and approving change controls, deviations, CAPAs and QA protocols.
• Knowledge of GDP and electronic quality systems is highly desired.
• Ability to collaborate with Manufacturing, Engineering and Process Development.

Responsibilities

• Review and approve MPs, validation protocols and reports.
• Approve EMS/BMS alarms, environmental reports and change controls.
• Lead site audits and investigations, own QA procedures.
• Represent QA on NPI team and support incident triage.
• Provide lot disposition and authorize shipments.

Skills

Project management

Organization

Cross-functional leadership

Negotiation

Regulatory interaction

Data trending

Independent work

Communication skills

Education

Doctorate or Master’s + 3 yrs rel exp; or Bachelor’s + 5 yrs rel exp; or Associate’s + 10 yrs rel exp; or HS diploma + 12 yrs rel exp

Tools

Electronic Quality Systems

GDP knowledge

CAPA management tools

Job description

• Lead site audits.

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role

Perform one or more of the following duties and responsibilities in support of 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.

Shift: Administrative

Location: Juncos, PR

Education:

Doctorate degree or Master's degree and 3 years of directly related experience or Bachelor's degree and 5 years of directly related experience or Associate's degree and 10 years of directly related experience or High school diploma / GED and 12 years of directly related experience.

Preferred Qualifications

• 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.

Skills

• 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.

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.