Job Responsibilities:
- Lead investigations for Out of Specifications results and implement corrective actions.
- Ensure operational compliance with US and international regulatory agencies and guidelines (FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- Investigate Exceptions to Standard Operating Procedures and implement necessary measures.
- Generate and review Change Controls for Standard Operating Procedures, Test Methods, Data Sheets, etc.
- Utilize quality tools (FMEA, Fishbone, 5 Why, Risk Analysis, HFAT, etc.) for investigations and special projects.
- Perform statistical analysis of laboratory data to support investigations, cost savings, and continuous improvement initiatives.
- Develop, execute, and manage protocols for Method Validations and Equipment Qualifications, including work with radioactive materials.
- Ensure a safe and quality working environment through training, awareness, and compliance with safety/quality guidelines and SOPs.
- Stay updated on US and international regulations related to Microbiology, Chemistry, and cGMPs.
- Provide support for on-site audits conducted by regulatory agencies (FDA, HC, EU, TGA, etc.).
Requirements:
- Bachelor of Science in Biology, Chemistry, or a related field is required.
- Three or more years of relevant experience is necessary.
- Preferred experience in investigating exceptions and out-of-specification results.
- Ability to resolve problems, handle conflict, make effective decisions under pressure, and conduct Root Cause Analysis.
- Proficiency in simple to complex math calculations, data input, and analysis.
- Strong multitasking skills to handle various projects simultaneously.
- Proficient in the use of Microsoft Office suite.
- Good computer skills, including data entry programs.
- Hands-on, analytical, and effective problem-solving and decision-making skills.
- Excellent written and verbal communication skills.
- Ability to work independently and collaboratively to achieve goals and priorities.
- High energy level and consistent attendance.
- Verifiable working knowledge of cGMP guidelines and their application in a pharmaceutical manufacturing environment.
Contact your Recruiter:
For more information about the role and to express your interest, you can reach out to our recruiter, Zhanri, directly:
- Email: zdesphy@harbasolutions.com
- Phone: 617.284.4255
About Harba Solutions:
Harba Solutions is a leading scientific services firm operating across a range of scientific industries including pharmaceuticals, biotechnology, medical devices, contract research organizations, and agricultural sciences. With a substantial network of qualified scientific candidates and ongoing interactions with emerging talents, we specialize in effectively placing scientific professionals in roles encompassing laboratories, chemistry, biology, and quality-focused disciplines, to name a few. Backed by strategic investors, our core values of commitment, work ethic, team and self-ownership, craft mastery, and pursuit of success shape our mission. Explore the opportunities at Harba Solutions and become part of the evolution of scientific services.
