Senior Quality Analyst/ Quality Assurance (QA) Specialist II

Creative Solutions Services, LLC; Barceloneta (PR); On-site; USD 41,000 - 45,000; Full time

Job summary

Creative Solutions Services, LLC seeks a Senior Quality Analyst/QA Specialist II in Barceloneta, PR for a 12-month onsite assignment. The role focuses on implementing and maintaining the Quality System and supporting manufacturing operations in investigations, risk assessment, and product disposition.

Responsibilities include ensuring GMP compliance, leading investigations, and collaborating with QA and Plant departments.

Qualifications

• Bachelor's degree in a scientific/engineering discipline and 4+ years in pharma/biotech quality/compliance.
• Experience with GMP, investigations, risk management, and regulatory standards for biological products.
• Strong written and spoken communication in English and Spanish.

Responsibilities

• Support quality goals and ensure compliance with policies and regulations for Quality areas.
• Lead and back up QA Manager, supporting quality initiatives across the plant.
• Conduct product impact analyses and approve investigations and risk-based evaluations.

Skills

Quality management

GMP knowledge

Regulatory compliance

Investigations

English/Spanish bilingual

Education

Bachelor's degree in Biotechnology/Biology/Chemistry/Engineering

Master's degree in Science preferred

Job description

Title : Senior Quality Analyst/ Quality Assurance (QA) Specialist II

Location: Barceloneta, PR (Onsite)

Duration: 12 months

Pay Range: $30/hr - $33.54/hr

Schedule:

Candidates must be available for any shift/weekend/holidays.

Associate Rotating shift - 4 days at 10 hours

2 months rotation on each shift 1, 2, 3 shift

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 :

• Support routine operations to ensure that all quality goals are met, and all practices and procedures comply with 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 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.