Quality Assurance Senior Specialist
Serán BioScience
Summary
Serán is seeking a Quality Assurance Senior Specialist who will be responsible for performing the day-to-day tasks of the QA Department supporting a GMP facility manufacturing, storing, and testing pharmaceutical products. Primary responsibilities include overseeing Supplier Quality, Auditing (supporting regulatory and client audits, conducting internal and vendor audits), and managing the Quality Risk Management program. Tasks include audit management, audit response, facilitating audit related continuous improvements, negotiating/processing Quality Agreements and continuous improvement. Additional responsibilities include Quality Management System, risk analyses, change management and investigations/CAPA.
Job description
Duties & Responsibilities
- Performs internal and third-party audits.
- Supports regulatory inspections and client audits. Manages and improves audit program.
- Provides direction on audit operational activities and the development of audit responses, CAPA plans, and Effectiveness Checks.
- Oversees company’s supplier quality program including supplier qualification and audit (some travel required)
- Assists in the oversight, facilitation, and implementation of continuous improvement of the company’s quality systems
- Administers the quality risk management program and conducts risk assessments
- Document authorship, review, and approval of SOPs, reports, and quality records.
Required Skills & Abilities
- Knowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211).
- Knowledge of GMP, FDA, and EMA expectations for clinical trial and commercial materials, manufacturing, and testing
- Excellent verbal and written communication skills
- Excellent time management skills with a proven ability to meet deadlines
- Excellent organizational skills and attention to detail
- Demonstrated ability to collaborate and work in cross-functional teams
- Scientific curiosity and willingness to learn
- Strong analytical and problem-solving skills
- Ability to prioritize tasks and to delegate them when appropriate
Education & Experience
- Minimum of a Bachelor's Degree, preferably in a scientific discipline
- 8+ years previous quality assurance experience including Auditing and Supplier Quality experience
- Working knowledge of Veeva preferred
Requirements
- Knowledge of GMP and FDA regulations for drug manufacturing (21CFR 210-211)
- Knowledge of GMP, FDA, and EMA expectations for clinical trial and commercial materials, manufacturing, and testing
- Excellent verbal and written communication skills
- Excellent time management skills with a proven ability to meet deadlines
- Excellent organizational skills and attention to detail
- Demonstrated ability to collaborate and work in cross-functional teams
- Scientific curiosity and willingness to learn
- Strong analytical and problem-solving skills
- Ability to prioritize tasks and to delegate them when appropriate
- Minimum of a Bachelor's Degree, preferably in a scientific discipline
- 8+ years previous quality assurance experience including Auditing and Supplier Quality experience
- Working knowledge of Veeva preferred
Benefits
- Paid time off
- Retirement account
- Health plans
- Basic life insurance
- Long-term disability
- Employee assistance program
- Pet insurance
Company overview
Serán BioScience is a biotechnology company focused on innovative research and development in the life sciences sector. The company specializes in advancing scientific discoveries and developing novel therapeutic approaches to address unmet medical needs. With a name suggesting Spanish or Latin American origins, Serán BioScience likely operates in the global biotechnology landscape, potentially focusing on areas such as drug discovery, biologics development, or specialized biopharmaceutical research. The company's mission appears to center on translating scientific breakthroughs into practical applications that can improve patient outcomes and advance medical science. As a biotechnology firm, Serán BioScience would typically engage in cutting-edge research, collaborate with academic institutions, and work toward developing proprietary technologies or therapeutic candidates. The company's operations likely involve a combination of laboratory research, preclinical studies, and strategic partnerships within the broader biotechnology ecosystem.