Sr Mgr QA Compliance - I*
American Cybersystems, Inc.

Job Info

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Innova Solutions is immediately hiring a Sr Manager, Quality Assurance - Global Product Distribution & Affiliates

Position type: Full-time Contract
Duration: 12 months and possibility for extension
Location: La Verne CA

As a Sr Manager, Quality Assurance, you will:

*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/hosting FDA 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 applicable regulatory requirements as it pertains to a US and Global product distribution operation.
• Maintains routine programs and processes to ensure high quality products and compliance with FDA 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 with Supply Chain, Warehouse, Customer Service personnel as well as facilities, EHS and validation colleagues in all aspects of product 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 of documentation 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 external regulators/stakeholders.
• Co-hosts/supports external FDA audits and internal audit programs.
• Participates in the development & delivery of training programs regarding relevant to US and Global product Distribution.
• Conducts or serves as a coordinator of investigations and corrective and preventive action (CAPA) recommendations as well as Change Management related to QA Operations.
• Conducts gap analyses and risk assessments of processes & procedures against relevant GDP guidelines as well as corporate standards.
• Participate in or where relevant lead local and corporate projects and process improvement initiatives, as required.

Knowledge, Experience & Behaviors:

• Experience in US market and international product distribution, to include supporting/hosting FDA and State Pharmacy Board inspections.
• Demonstrates proficiency in Good Distribution Practices (GDP), Verified-Accredited Wholesale Distributors (VAWD) and Drug 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.
• Organized with systematic approach to prioritization.
• Positive attitude
• Motivated to learn new skills and embrace new experiences.

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

Thank you!

Vishnu Kaushik
Email: vishnu.kaushik@innovasolutions.com
Phone - 678-207-5230

PAY RANGE AND BENEFITS:
Pay Range*: $75- $80 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 centers 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.

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 hr@innovasolutions.com 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.

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