GxP Supplier Quality Contractor from AIC

Innova Solutions is immediately hiring for a GxP Supplier Quality Contractor

Position type: Full time Contract.

Duration: 12 months

Location: South San Francisco, CA

As a GxP Supplier Quality Contractor , you will:

Job Description:

Main Purpose of the Position Support External Quality GxP Supplier Quality Managers in the following key aspects of their role:

Provide quality and compliance oversight for external GxP suppliers including CMO CLO suppliers or distributors of direct materials or critical process-contacting spare parts suppliers for analytical equipment or manufacturing systems and service providers to ensure compliance with cGMP and Quality Agreement requirements

Manage designated suppliers and participate as part of GxP supplier cross-functional management teams to enable as applicable for the supplier lifecycle stage site selection and implementation including due diligence activities ongoing quality supply of commercial products materials or services from suppliers and decommissioning.

Technical Job Responsibilities:

Support External Quality GxP Supplier Quality Managers in the following activities associated with their role:

Oversee all required quality activities during the lifecycle of a GxP supplier Source Select Implement

Manage and Decommission including but not limited to: process or method validations client and Health Authority audits complex investigations market complaints and regulatory submissions

Develop negotiate and maintain risk-based Quality Agreements and Product Specific Requirements as appropriate with GxP suppliers and ensure compliance with agreements

Collaborate with GxP suppliers to address gaps of audit responsiveness CAPA implementation deviation reporting and management complaint management investigation closure and change implementation with regard to quality and time with the supplier and escalate as appropriate

As applicable collaborate with GxP suppliers to maintain the manufacturing processes and the Specifications and Analytical Methods SAM in a validated state and compliant with the regulatory dossier including stability testing programs

As applicable develop and maintain quality risk management plans utilize risk management tools to identify and mitigate supplier quality and compliance risks ensuring suppliers are in a state of continuous inspection readiness

As applicable support or lead supplier improvement initiatives to solve complex manufacturing or quality problems. Identify design and implement process and system improvements.

This includes support for implementation of or changes to enterprise-wide systems such as SAP Veeva and MDMS/GLAS.

Functional Job Responsibilities

Collaborate and manage relationships across supplier management and internal cross-functional teams to ensure quality expectations are aligned with client objectives.

Notify relevant GxP Supplier Quality Managers and/or Senior Management of potential quality or regulatory issues impacting product quality or regulatory compliance.

Troubleshoot and drive the resolution of quality issues fostering effective interdepartmental and cross-functional partnerships.

Sign documents as authorized and described by Client policies procedures and job descriptions. Be accountable for behaviors described in client Code of Conduct. Deliver business outcomes in support of departmental objectives.

Maintain and communicate work priorities to meet goals and timelines. Timely complete all job-related training requirements before performing GMP-job functions and strive to continuously improve knowledge and skills in quality compliance and technology.

Perform other quality-related activities and projects to ensure quality compliance and continuous improvement. Train other interns as required

Qualifications and Skills

B.A. or B.S. degree in life sciences or equivalent Previous experience in the pharmaceutical or related industry or an equivalent combination of education and experience is a plus

Ability to interpret quality standards as they relate to GxP suppliers Operational Excellence expertise is a plus

Highly competent in MS Office or Google Suite applications including Excel PowerPoint Word and MS Project etc.

Ability to communicate clearly and professionally both in writing and verbally

Note:

They are looking to find a contractor with QC experience within these levels: Level II 3-5 Years experience Level III 5-7 Years experience

Qualified candidates should APPLY NOW for immediate consideration! Please hit APPLY to provide the required information, and we will be back in touch as soon as possible.

We are currently interviewing to fill this and other similar positions. If this role is not a fit for you, we do offer a referral bonus program for referrals that we successfully place with our clients, subject to program guidelines. ASK ME HOW.

Thank you!

Namrata Gautam

Senior Associate Recruitment

PHONE: (+1) 314-523-1818

EMAIL:

PAY RANGE AND BENEFITS:

Pay Range*: $65- $77 per hour.

*Pay range offered to a successful candidate will be based on several factors, including the candidate's education, work experience, work location, specific job duties, certifications, etc.

Benefits: Innova Solutions offers benefits( based on eligibility) that include the following: Medical & pharmacy coverage, Dental/vision insurance, 401(k), Health saving account (HSA) and Flexible spending account (FSA), Life Insurance, Pet Insurance, Short term and Long term Disability, Accident & Critical illness coverage, Pre-paid legal & ID theft protection, Sick time, and other types of paid leaves (as required by law), Employee Assistance Program (EAP).

ABOUT INNOVA SOLUTIONS: Founded in 1998 and headquartered in Atlanta, Georgia, Innova Solutions employs approximately 50,000 professionals worldwide and reports an annual revenue approaching $3 Billion. Through our global delivery centres across North America, Asia, and Europe, we deliver strategic technology and business transformation solutions to our clients, enabling them to operate as leaders within their fields.

Recent Recognitions:

• One of Largest IT Consulting Staffing firms in the USA - Recognized as #4 by Staffing Industry Analysts (SIA 2022)
• ClearlyRated® Client Diamond Award Winner (2020)
• One of the Largest Certified MBE Companies in the NMSDC Network (2022)
• Advanced Tier Services partner with AWS and Gold with MS

Website: https://www.innovasolutions.com/

Innova Solutions is an Equal Opportunity Employer and prohibits any kind of unlawful discrimination and harassment. Innova Solutions is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment on the basis of race, color, religion or belief, national origin, citizenship, social or ethnic origin, sex, age, physical or mental disability, veteran status, marital status, domestic partner status, sexual orientation, or any other status protected by the statutes, rules, and regulations in the locations where it operates. If you are an individual with a disability and need a reasonable accommodation to assist with your job search or application for employment, please contact us at or (770) 493-5588. Please indicate the specifics of the assistance needed. Innova Solutions encourages all interested and qualified candidates to apply for employment opportunities. Innova Solutions (HireGenics/Volt) does not discriminate against applicants based on citizenship status, immigration status, or national origin, in accordance with 8 U.S.C. § 1324b. The company will consider for employment qualified applicants with arrest and conviction records in a manner that complies with the San Francisco Fair Chance Ordinance, the Los Angeles Fair Chance Initiative for Hiring Ordinance, and other applicable laws.

American Cybersystems, Inc is acting as an Employment Business in relation to this vacancy.