Supplier Quality Assurance
Supplier Quality Assurance
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$ 89680 - 140125
1 Vacancy
Job Description
Job Description
This position provides Quality Assurance (QA) oversight to Suppliers Service Providers and Contract Labs to ensure compliance with applicable regulatory requirements and Standard Operating Procedures (SOPs). Serves as the quality liaison to suppliers and executes and leads on-going qualification for Suppliers Service Providers and Contract Labs.
Individuals with this position may act as delegates for each other.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Leads or supports the supplier management program. Suggests develops and/or implements improvements to the program to ensure it maintains compliance with current regulatory and industry expectations.
Leads and Performs new material and new supplier on-boarding process
Performs on-site audits to ensure compliance to regulatory standards and internal procedures. Completes audit reports and ensures appropriate CAPAs are identified by the supplier when necessary. Site audits require up to 25% travel both domestic and international.
Performs desk top audits to ensure compliance to regulatory standards.
Responsible for the Material Review Board process. Schedules and facilitates meetings ensuring cross-functional input and decision making on supplier related topics including real-time monitoring of supplier performance and documentation of supplier score cards.
Leads Supplier Complaints to ensure investigation into issues are completed and appropriate CAPAs are identified and implemented by the supplier.
Leads the Raw Material Change Evaluation process.
Leads and maintains Quality Agreements with suppliers.
Coordinates and performs supplier risk assessments with inputs from cross-functional teams.
Provides input into investigations involving Supplier/Service Provider/Contract Lab deviations.
Responsible for writing reviewing and/or approving documentation and procedures related to the supplier management program.
Provides support on various other quality assurance issues as necessary.
May disposition raw materials including rejection of materials in collaboration with the Manufacturing QA team.
Assists with client and regulatory audits as requested by management.
Assists in conducting internal audits as requested by management.
MANAGERIAL RESPONSIBILITIES:
This job has no managerial responsibilities but may make recommendations on hiring training scheduling of work tasks and mentor of employees.
KNOWLEDGE SKILLS AND ABILITIES:
Knowledge of GMP guidelines as well as international regulations pertaining to the production of APIs and drug products.
Knowledge and understanding of the oligonucleotide manufacturing or related pharmaceutical manufacturing processes.
Experience or training in performing quality audits in a GMP and ISO environment.
Skill in communication written and verbal; will be handling various relations issues and will be confronted with various interactions. Ability to respond to common inquiries or complaints from Suppliers Service Providers Contract Labs customers co-workers and supervisors regarding products materials and processes.
Ability to write reports business correspondence and procedures.
Must be a problem solver who uses advanced analytical skills to find innovative solutions to supplier quality related systems.
Ability to read analyze and interpret industry related periodicals SOPs and government regulations.
Skill in leading various projects; must be able to use individual discretion in completing work assignments; while assisting the group in establishing priorities setting standards and working collectively to accomplish deadlines and objectives.
Knowledge of and skill in using computer software and hardware applications including Microsoft products and the Internet.
Qualifications
Bachelors or Masters Degree or equivalent.
Post-graduate certification and/or license may be required.
4 years relevant experience in supplier management related experience; or equivalent combination of education and experience.
Prior experience and/or training working in a GMP production environment is required.
Knowledge of SAP inventory system beneficial and preferred.
Additional Details
This job has a full time weekly schedule. Applications for this job will be accepted until at least July 21 2025 or until the job is no longer posted.The full-time equivalent pay range for this position is $89680.00 - $140125.00/yr plus eligibility for bonus stock and benefits. Our pay ranges are determined by role level and location. Within the range individual pay is determined by work location and additional factors including job-related skills experience and relevant education or training. During the hiring process a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Technologies Inc. is an Equal Employment Opportunity and Affirmative Action employer. We value diversity at all levels. All individuals regardless of personal characteristics are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex pregnancy race religion or religious creed color gender gender identity gender expression national origin ancestry physical or mental disability medical condition genetic information marital status registered domestic partner status age sexual orientation military or veteran status protected veteran status or any other basis protected by federal state local law ordinance or regulation and will not be discriminated against on these bases. Agilent Technologies Inc. is committed to diversity in the workplace and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility please email or contact 1-. For more information about equal employment opportunity protections please visit Required: 10% of the TimeShift:
DayDuration:
No End DateJob Function:
Quality/RegulatoryEmployment Type
Full-Time
