JT712 - SR. SPECIALIST QA

Quality Consulting Group, LLC; Juncos (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

Quality Consulting Group, LLC is seeking a talented, highly motivated QA professional to join our team in Puerto Rico & USA. In this role, you’ll approve process validation protocols, lead investigations, and own program procedures, representing QA on cross-functional teams and CCRB.

You will manage commissioning/qualification activities, environmental characterization, and the release of sanitary utility systems, while collaborating with regulators and internal stakeholders to ensure compliance

Qualifications

• Bachelor's degree in related area required.
• 6 years of directly related experience required.
• Experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, Good Documentation Practices, Change Controls, SOPs.
• Project management skills essential.
• Strong organizational skills with ability to follow assignments through to completion.
• Strong knowledge of manufacturing and distribution QA, QAL, validation and processes development.
• Demonstrated ability to interact with regulatory agencies.
• Strong word processing, presentation, database and spreadsheet skills.
• Excellent written and oral communication, facilitation and presentation skills.

Responsibilities

• Approve process validation protocols and reports for manufacturing processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

Skills

6 years of directly related experience

Project management

Strong communication

Strong organizational skills

Data trending and evaluation

Regulatory interactions

QA, QAL, validation processes

Education

Bachelor's degree in related area

Tools

Kneat

Good Documentation Practices

Change Controls

SOPs

QRAES

Job description

QUALITY CONSULTING GROUP, a leader inthe pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Approve process validation protocols and reports for mfg. processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

Qualifications:

• Bachelor's degree in related area
• 6 yearsof directly related experience
• Experience in Commissioning and Qualification, Equipment validation, QRAES, Kneat, Good Documentation Practices, Change Controls, SOP’s etc
• Project management skills.
• Strong organizational skills, including ability to follow assignments through to completion.
• Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development.
• Demonstrated 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.
• Advanced data trending and evaluation.
• Ability to evaluate compliance issues.

Quality Consulting Group, LLC is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.