Sr Quality Assurance Product Manager (GDP/GMP, FDA, Supply Chain
Cube Hub Inc La Verne
Job Title
- Sr Quality Assurance Product Manager (GDP/GMP, FDA, Supply Chain)Location
- La Verne, CAJob Duration: 10 monthsLa Verne
- On site for 3 core collaboration days minimum Description:Sr QA Manager,
- Global Product Distribution & Affiliates.
- Preferred Education Level: 8+ years of experience in a GDP/GMP environment related field and a BS or BA, or 6+ years of relevant experience and a MS.
Experience in US market and international product distribution, to include supporting/hostingFDA and State Pharmacy Board inspections.
Experience in applying QRM.Ideally will have provided QA oversight of contracted 3PL services* Performs a wide variety of activities to ensure compliance with applicableregulatory requirements as it pertains to a US and Global product distribution operation.
Maintains routine programs and processes to ensure high quality products and compliance withFDA current Good Distribution Practice (GDP) and National Association or Boards of Pharmacies (NABP) Verified-Accredited Wholesale Distributors (VAWD) requirements.
Supports Global and Regional QA teams as well as working cross-functionally withSupply Chain, Warehouse, Customer Service personnel as well as facilities, EHS and validation colleagues in all aspects ofproduct distribution.Interfaces with and provides QA oversight of contracted 3PL activities pertaining to product distribution and process performance issues.
Participates in developing Standard Operating Procedures (SOPs) and other types ofdocumentation to ensure quality objectives are met.
Reviews shipping records, environmental monitoring and associated data relating to product distribution activities.
Hosts NAPB external audits and interacts closely with externalregulators/stakeholders.
Co-hosts/supports external FDA audits and internal audit programs.
Participates in the development & delivery of training programs regarding relevant to US andGlobal product Distribution.
Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well asChange Management related to QA Operations.
Conducts gap analyses and risk assessments of processes & procedures against relevantGDP guidelines as well as corporate standards.
Participate in or where relevant lead local and corporate projects and process improvement initiatives, as required.
Knowledge, Experience & Behaviours: Experience in US market and international product distribution, to include supporting/hostingFDA and State Pharmacy Board inspections.
Demonstrates proficiency in Good Distribution Practices (GDP), Verified-Accredited Wholesale Distributors (VAWD) andDrug Supply Chain Security Act (DSCSA) requirements.
Demonstrates working knowledge with good proficiency in Microsoft Office applications.
Experience in providing QA oversight of contracted 3PL activities.
Resilient profile with the ability to deliver in a challenging environment.
Ability to engage and manage multiple stakeholders to achieve the objective.
Organised with systematic approach to prioritisation.
Positive attitude Motivated to learn new skills and embrace new experiences.
Gentex CorporationRancho Cucamonga, 9 mi from La Verne
from an accredited college, or an equivalent combination of education and experience related to aerospace manufacturing Quality Assurance.
PREFERRED QUALIFICATIONS:
• Minimum of 10 years of aerospace manufacturing quality assurance experience...
La Verne
Job Overview:
The Senior Chemist works on the Quality Assurance (QA) Team and serves as a technical specialist to support the Quality Assurance Program and Metropolitan's water quality laboratory accreditation related to the microbiology...
Northwest PartnersLos Angeles, 29 mi from La Verne
Northwest Partners has an opportunity for a Quality Assurance Analyst with a financial services background for a client in the FinTech industry. Applicants must be authorized to work for ANY employer in the US. We are unable to sponsor or take over...