Quality Assurance Specialist - Supplier Quality
Bionova Scientific LLC Job Description: Position Summary: This role is part of the Quality Assurance Compliance team. As a member of the QA team, the role incumbent has GMP Quality experience assessing supplier's compliance and managing the BNS supplier qualification program. The role also supports Bionova Scientific's self-inspection program, as well as management of the client audits and health authority inspections. The position requires a high attention to detail, to be organized in their work, strong written and verbal communication skills and working well independently and in a team environment. Position Responsibilities: • Assessing potential suppliers through thorough reviews of their quality systems, manufacturing processes, and capabilities to ensure they meet required quality standards • Interface with internal and external suppliers/clients to request/obtain required material and supplier documentation, establish quality agreements as applicable, etc. • Negotiating and maintaining quality agreements with suppliers, outlining expectations regarding product specifications, quality control procedures, and reporting requirements. • Perform actions associated with Change Control documents, discrepancy management and supplier investigations • Conducting regular on-site audits at supplier facilities to verify compliance with established Bionova quality requirements, GMP practices, and documented procedures • Identifying potential quality risks associated with suppliers and implementing mitigation strategies to minimize risks to product quality • Maintaining open communication with suppliers, procurement teams, and internal quality departments to address quality concerns and drive continuous improvement • Enforce quality assurance policies and procedures to maintain product quality and compliance. • Investigating and managing discrepancies that may impact product quality, ensuring proper documentation and corrective actions are taken • Compile metrics for presentation to senior management and communicate disposition status in a timely manner • Coordinate the inspection readiness program for Bionova Scientific • Preparing for and supporting regulatory agency audits, client audits and self-inspection Working Conditions: This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 15 pounds independently. Qualifications: • Bachelor of Science degree or equivalent in a scientific field • Minimum of 5 years' GMP Quality Assurance and Quality Systems experience. Experience with ERP systems and eQMS systems is a must • Expertise in data analysis, trend analysis. • Strong understanding of pharmaceutical manufacturing processes and documentation requirement • Excellent written and verbal communication skills to effectively document findings and present technical information • Working knowledge of GMP regulations and guidance (21 CFR 210/211/11, ANNEX 1, ICH, etc.)• Effective organization and planning skills. Demonstrated ability to deal with frequent changes, delays, or unexpected events • Effective interpersonal and communication skills. Communication at all management levels and all staff is required • Proficiency with relevant quality management systems and software Compensation Range: The base compensation range for this role is between $95,000 and $110,000. However, the actual compensation may vary depending on your experience and qualifications. Health Benefits and Program: Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) Up to 8% of Employer Match Paid time off up to two weeks 10 days of Holidays and 5 days of Sick Leave. As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.
Recommended Jobs
Program Therapist (LMFT/AMFT / LCSW/ACSW / LPCC/APCC)
Job Description Job Description Position Summary The Program Therapist provides clinical services to clients in individual, family, and group settings. The therapist conducts biopsychosocial a…
Call Center Inside Sales Associate
The Bilingual Call Center Representative plays a crucial role in our company by connecting with residential owners and renters to inform them about our valuable programs. This position involves makin…
War Hazards Clerk
Goldberg Segalla is a national civil litigation law firm that represents major national and regional companies and insurance carriers in all aspects of business counseling, risk assessment and disput…
Unarmed Field Supervisor
Job description: American Guard Services is looking for a Field Supervisor in Southfield Michigan! PAYRATE: $18.75 PERKS OF WORKING WITH AGS! WEEKLY PAY FULL TIME EMPLOYEES CAN BE PROVIDE…
Night Audit I - Hospitality
Job Description Job Description Job Title: Night Audit I Company: Highway West Vacations Location: Sideways Inn Buellton Full-Time/Part-Time: Part Time , Non-Exempt Supervisor:…
Forklift Operator- Expert
Title: Forklift Operator Expert Salary Range: $25.50 Hourly Status: Non-Exempt Days/Shifts: B Shift, Monday - Saturday Location: Salinas, CA ___________________________________________…
Part Time Prepared Foods Team Member (Deli Service Counter & Culinary Venues)
A career at Whole Foods Market is more than just the work you do- it's about your personal growth and creating meaningful change. Our purpose is to nourish people and the planet. That means improving…
Office Chief
Job Description and Duties This is a management level position with responsibility for the project delivery of plans for buildings and other transportation-related structural projects for Caltrans…