Senior Quality Analyst

On site

ALL candidates must be available for any shift/weekend/holidays. Associate Rotating shift – 4 days at 10hours 2 months rotation on each shift 1st, 2nd, 3rd shift Area worked based in manufacturing schedule of 24/7

Is overtime offered or required? Must be available to work OT based in business needs

Senior Quality Analyst

Purpose :

Describes the primary goals,objective or function or outputs of this position.

• 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 :

List up to 10 main responsibilities for the job. Include information about the accountability and scope.

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with Client 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 Client 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 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.
• Assures the quality of manufactured products and processes per standard operating processes(SOP'S) and GMP (Good Manufacturing Practices).
• BS degree or 3-5 years equivalent experience.

Experience Level = 3 to 5 Years