Specialist QA

Pinnaql, Inc.; Puerto Rico; On-site; USD 90,000 - 130,000; Full time

Job summary

Validation & Engineering Group, Inc., a Pinnaql company, is seeking a Specialist QA to support quality assurance across GMP manufacturing environments in the United States.

You will review MPs, approve validation protocols, lead investigations, and drive CAPA, change controls, and deviations while coordinating with Manufacturing, Engineering, and Process Development. Bilingual English/Spanish preferred.

Qualifications

• GMP manufacturing knowledge is required.
• Experience reviewing and approving change controls, deviations, CAPAs, and protocols.
• Strong data trending, documentation, and record-keeping skills.
• Fluent English and Spanish communication preferred.

Responsibilities

• Review and approve product MPs.
• Approve process validation protocols and reports for manufacturing processes.
• Lead investigations and drive CAPA closure.
• Own site quality program procedures and QA documentation.
• Collaborate with Manufacturing, Engineering, and Process Development.
• Provide lot disposition and authorize lots for shipment.

Skills

GMP knowledge

CAPA management

Change controls

Root cause analysis

Bilingual English/Spanish

Education

Doctorate or MS + 2 years experience

Bachelor's +4 years experience

Associate +8 years experience

High school/GED +10 years experience

Job description

Current job opportunities are posted here as they become available.

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.
• Release of sanitary utility systems.
• Approve planned incidents.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.
• 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.
• 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.