Senior Quality Analyst

AbbVie Inc.; Barceloneta (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

AbbVie Inc. is seeking a Senior Quality Analyst to support the Quality Manager in implementing the Quality System, CAPA administration, and investigations for manufacturing operations.

The role involves evaluating events, guiding risk assessments, and ensuring product disposition in alignment with regulatory requirements. The candidate will back up the QA Manager, lead investigations, approve SOPs and change documents, and collaborate across Quality and Plant departments.

Qualifications

• Bachelor's degree in biotechnology, biology, chemistry or engineering is required.
• Master's degree in science is preferred.
• Four years of pharmaceutical/biotechnology industry experience in a similar role.

Responsibilities

• Supports routine operations to ensure quality goals and compliance with AbbVie policies and regulations.
• Lead investigations of plant events and document in the CAPA system.
• Perform product impact analyses and manage QA holds as needed.
• Participate in Validation Review Board and approve SOPs, change and risk documents.
• Approve calibration requests and preventive maintenance records with proper justifications.
• Coordinate with other Quality areas and plant departments to align practices.
• Assist Compliance during internal and external audits.
• Guide new product introductions with risk assessments and material control until regulatory approval.
• Ensure EHS requirements and change processes meet compliance standards.

Skills

Quality/compliance management

GMP knowledge

Bilingual communication (English/ES)

Investigations & risk management

Safety regulations awareness

Education

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

Master's Degree in Science (Biotechnology, Biology, Chemistry or Engineering)

Job description

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Job Description

Purpose:

The Senior Quality Analyst position supports the activities and initiatives of the Quality Manager to implement and manage the Quality System (CAPA Administrator). 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 AbbVie 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 AbbVie 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. Oversees 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.


• Conform to EHS management system requirements and compliance obligations, promote continuous improvement, and consider EHS aspects during the design and change process. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

Qualifications

• Bachelors Degree in Biotechnology, Biology, Chemistry or Engineering. Masters Degree in Science (Biotechnology, Biology, Chemistry or Engineering), 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future.


• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.


• This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefit that are allocable to a particular employer remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation.