Quality Analyst

Kelly Services; Barceloneta (PR); In loco; USD 60.000 - 85.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical benefits

Retirement savings plan

Paid holidays

Descrizione del lavoro

Kelly Science, Engineering, Technology & Telecom (SETT) is seeking a Quality Analyst to join a leading biopharmaceutical client in Barceloneta, PR. The role focuses on implementing and maintaining the Quality System, supporting manufacturing events, investigations, and product disposition.

Ideal candidates will have a Biotech/Engineering background, 4 years in pharma/biotech, and strong English and Spanish communication. This position offers growth within a global team.

Competenze

• Bachelor's degree in biotechnology, biology, chemistry, or engineering.
• Four (4) years of pharmaceutical/biotechnology industry experience in a similar role.
• Knowledge of GMP, quality/compliance, investigations, risk management, and regulatory guidelines.

Mansioni

• Support routine operations to ensure quality goals and regulatory compliance.
• Back up QA Manager and support quality initiatives.
• Lead investigations and CAPA in plant operations and perform product disposition.
• Approve SOPs, change management, and risk management documents with proper justifications.
• Collaborate with cross-functional teams and support internal/external audits.

Conoscenze

Quality/compliance

GMP knowledge

Bilingual English/Spanish

Formazione

Bachelor's degree in Biotechnology, Biology, Chemistry or Engineering

Master's Degree in Science preferred

Descrizione del lavoro

At Kelly® Science, Engineering, Technology & Telecom (SETT) , we’re passionate about helping you find a job that works for you. How about this one?

We’re seeking an Quality Analyst to work with one of our top global biopharmaceutical clients in the Barceloneta PR area. With us, it’s all about finding the job that’s just right

Purpose:

Responsible for implementing and maintaining the effectiveness of the Quality System. Support manufacturing operations in the resolution of events, impact assessment and documentation discrepancies. Provide guidance for product/process impact analysis, perform holistic evaluation of events, review and approve investigations and risk-based evaluations in support to routine operations and product disposition.

Responsibilities:

Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with Customer policies and applicable regulations for the Quality areas under responsibility. Serve as backup for the QA Manager leading the team and providing support to quality initiatives.

Ensures investigations of plant events are evaluated in a timely manner; completed thoroughly and documented accurately in the plant CAPA system.

Performs product impact analyses for plant events and places product on QA hold where appropriate.

Participates on the Validation Review Board as the Manufacturing Quality Assurance function.

Approves standard operating procedures; change management and risk management documents. Ensures all documents are in compliance with Customer global procedures and regulatory requirements.

Approves calibration requests, calibration out of tolerance and preventive maintenance records. Ensures that these documents have appropriate justifications according to product /process limits established.

• Demonstrates accountability and responsibility of EHS performance and compliance.

Maintains an effective liaison and cooperative relationship with other Quality areas and Plant departments. Oversee manufacturing operations to ensure practices are in alignment with approved procedures.

Provide support to the Compliance team during internal and external audits as required.

Provide guidance for new product introduction activities. Develop risk assessments to support manufacturing activities for new products and ensure material control until regulatory approval.

Qualifications: .

Bachelors degree in Biotechnology, Biology, Chemistry or Engineering. Masters Degree in Science preferred.

Four (4) years of experience in Pharmaceutical/Biotechnology industry in a similar position.

This position requires knowledge of quality / compliance /Investigations /Risk management as well as regulations and standards affecting biological products.

Excellent written and spoken communication skills in English and Spanish.

Knowledge of GMP, safety regulations.

Quality/compliance management skills.

Fast paced and adaptable to continuously changing environment. Subject to work with multiple priorities and interruptions and under reasonable pressure due to the nature and function of the area.

• New Product Introduction – experienced Quality representative to support manufacturing and technical operations for the introduction of new biological products filled under aseptic processing conditions. Required experience in parenteral filling operations for sterile drug products. Knowledgeable in the following aspects GMP, Media Fills, Process validation (PPQ), Smoke Studies, CAPA/Investigations, Root Cause Analysis, Change Management, Risk Management, Annex 1 and FDA regulatory guidelines. Responsibilities include, develop, review and approval of protocols, technical reports, investigations, procedures, risk assessments. Provide guidance to cross functional team on the requirements and compliance aspects governing the new product introductions.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Please note: The following benefits reflect Kelly's general offerings. Eligibility may vary by assignment, location, and job type. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here (https://www.mykelly.com/help-support-working-with-kelly-us/#Benefits) for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

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Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world’s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it’s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

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Kelly Services is proud to be an Equal Employment Opportunity and Affiliation employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly’s Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.