MV01-112224 Quality Assurance Specialist [Night Shift] Job at Validation & Engineering Group, Puerto Rico

RXBYVnJOMmpOMnVhWEtuN1FsR3djUUlD
  • Validation & Engineering Group
  • Puerto Rico

Job Description

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) 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 [Night Shift (5:00 PM to 5:30 AM 2-2-3)]

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

Functions:
  • 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.


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.

Competencies/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.

Preferred:

  • Fluent in English and Spanish, including writing.
  • Strong English technical writing skills.
  • Ability to complete tasks autonomously, providing updates to senior management, and identifying potential issues.
  • Problem solving skills.
  • Experience working with dynamic cross-functional teams and abilities in decision making.
  • Strong organizational skills, including ability to follow assignments through to completion.
  • Strong leadership capabilities and experience applying GMP requirements in an operational setting.
  • Ability to independently interact with various levels, drives tasks to completion, and is a self-starter.

Job Tags

Local area, Night shift,

Similar Jobs

SynergisticIT

Junior Software Engineer Job at SynergisticIT

 ...visa, Walmart labs, etc., to name a few. We have an excellent reputation with the clients. Currently, we are looking for Junior Software EngineerWho Should Apply Recent Computer Science/Engineering /Mathematics/Statistics or Science Graduates looking to make their careers... 

ICF Next

Campaign Manager (Health Communications) Job at ICF Next

 ...Job Description ICF, a leader in public health and driving health outcomes through science, technology, and communications, is seeking...  ...spectrum of issues impacting disease prevention and health promotion. The Campaign Manager shall be experienced managing a large... 

AZ Sales Group

Entry Level Business Manager Job at AZ Sales Group

 ...We are looking for a self-driven individual to join our management team to continue facilitating the success weve seen within...  ...clients, we need the ideal candidate to be developed into an entry-level Business Manager role. Our Business Managers oversee our team members... 

Marvs Quality Towing

No CDL Drivers wanted for Hauling Containers no CDL required We will train Job Job at Marvs Quality Towing

No CDL Drivers wanted for Hauling Containers no CDL required We will train JobWe are looking for professional individuals to join our team. We are looking for drivers to fill our container hauling non CDL trucks. Driver responsibilities would be, ensuring containers... 

Frank Ramirez District 82 Farmers Insurance

Farmers Insurance Agent Job at Frank Ramirez District 82 Farmers Insurance

 ...Description Our office is growing and we are looking to bring on a new insurance sales intern to fit into our close-knit office! As an insurance...  ...that all quotes, procedures, and practices are compliant with Farmers Department of Insurance. Work independently and with...