Validation & Engineering Group, Inc.

Quality Floor Shop Specialist

Validation & Engineering Group, Inc.  •  Carolina, PR (Onsite)  •  2 months ago
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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 Quality Shop Floor Associate to provide real-time quality oversight and support within a regulated manufacturing environment. This individual will work directly with Manufacturing, Engineering, and Quality teams to ensure production activities comply with approved procedures, Good Manufacturing Practices (GMP), and applicable quality requirements.

  • Quality Floor Shop Specialist

Description:

  • Provide quality oversight and support on the manufacturing floor
  • Verify that manufacturing activities follow approved procedures, specifications, and GMP requirements.
  • Review production documentation for accuracy, completeness, and compliance.
  • Support line clearance, material verification, equipment readiness, and production start-up activities.
  • Identify, document, and escalate quality issues and potential compliance concerns.
  • Support investigations involving deviations, nonconformances, manufacturing events, and product-quality issues.
  • Participate in root-cause analysis and corrective and preventive action activities.
  • Assist with the inspection, review, and disposition of materials and products.
  • Collaborate with Manufacturing and other departments to resolve quality issues promptly.
  • Maintain accurate and timely records in accordance with data-integrity requirements.
  • Support audits, inspections, and continuous-improvement initiatives.
  • Perform other quality-related responsibilities as assigned.

Minimum Qualifications

  • High school diploma or GED required.
  • Previous GMP experience is required.
  • Experience in quality, manufacturing, inspection, or production within a regulated environment.
  • Understanding of good documentation practices and data-integrity principles.
  • Ability to read, understand, and follow written procedures and specifications.
  • Strong attention to detail, communication, and problem-solving skills.
  • Ability to work effectively in a fast-paced, team-oriented manufacturing environment.
  • Availability to work assigned shifts and provide on-site shop-floor support.

Preferred Qualifications

  • Bachelor’s degree in Science, Engineering, Quality, or a related field is a plus but not required.
  • Experience in the medical-device, pharmaceutical, biotechnology, or other FDA-regulated industry.
  • Experience supporting deviations, nonconformances, investigations, CAPAs, and change controls.
  • Familiarity with electronic quality and manufacturing documentation systems.
  • Bilingual English and Spanish is preferred.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.

Validation & Engineering Group, Inc.

About Validation & Engineering Group, Inc.

Validation & Engineering Group, Proudly serving our clients since 1997.

Our Mission states in part: "provide our clients with the best resources to meet their needs". In our search for the best talent, we are inclusive and do not discriminate. V&EG is proud to be an equal opportunity workplace and is an affirmative action employer.

Validation & Engineering Group provides world-class service and expertise to the pharmaceutical, medical device and biotechnology industries. We offer our clients: Validation, Control System Solutions, Instrumentation, Training, Equipment Rentals, and Regulatory Compliance Services to ensure adherence to Federal and European regulatory agencies. Our group had serve in solid dosages, liquids, creams, lyophilizers, and parenteral dosage.

Our agility in responding to our clients’ needs, access to the best pool of talent, and the combined experience and technical expertise of our resources make Validation & Engineering Group a leader in the pharmaceutical, medical devices, and biotechnology industries.

At Validation & Engineering Group we provide professional expertise in the areas of:

•Audit and Assessment

•Automated Process Control System Qualification

•Equipment and Facilities Qualification

•Facilities Start-Up and Commissioning

•GAP Analysis

•Information Systems Computer Validation

•Packaging and Process Analysis

•Process & Cleaning Validation

•Project Management

•Quality Systems

•Risk Based Approach

•Regulatory Compliance

•Standard Operating and Maintenance Procedures

•Training

•Utilities Support and Qualification

In addition we offer Equipment Rentals and training to your workforce such as: Temperature & Relative Humidity, Electrical, Process, Environmental, and. Analytical.

Our Offices:

Puerto Rico:

Centro Internacional de Mercadeo I 100 Carr. 165 Ste 703, Guaynabo, 00968 Puerto Rico

Phone: (787) 622-0996

United States:

2180 Satellite Blvd, Suite 400Duluth, Georgia 30097 United States

Phone: (770) 403-5802

Industry
Architecture & Engineering
Company Size
51-200 employees
Headquarters
Guaynabo, PR
Year Founded
1997
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