Quality Assurance Specialist I

Position Overview

The QA Specialist is responsible for auditing the products and processes at various points in the areas of production and packaging to ensure adherence to company quality standards. Communicate any deviations to management. Assist the Quality Assurance team with special projects as required. Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards.

Regular working hours are M-Th 3PM-1:30AM.

The Role

• Conduct thorough and detailed quality audits of lines to ensure products meet established quality standards.
• Equipment verification including metal detector, x-ray, scales, etc.
• Audit paperwork of operators to ensure they are meeting quality standards
• Report any deviations to QA Supervisor in complete appropriate details.
• Report any housekeeping issues that need attention.
• Document all areas of non-compliance and ensure corrective action to eliminate them.
• Work with Production and Packaging Managers, Supervisors, and hourly associates on daily issues and problems.
• Utilize computer to enter and track result data.
• Comply with SQF, Food Safety Plan (HACCP), Food Quality Plan (FQP) standards.
• Responsible for ensuring compliance to FDA and cGMP standards for Quality Control, including continuous training.
• Other duties as assigned.

The Candidate

• For business and safety reasons, must be able to communicate effectively verbally and in written English.
• High School Diploma. BS in Food Science or related major is preferred.
• One year of Quality experience in a regulated environment preferred
• Ability to communicate with all line level positions and management
• Attention to detail
• Self starter and must be able to work independently with minimum supervision
• Able to assert himself / herself effectively
• Strong interpersonal skills are essential. Ability to develop cross functional and multinational relationships to support interaction with various internal customers.
• Strong analytical skills
• Ability to read and follow documents (Standard Operating Procedures and Test Methods)
• Knowledge of GMP and Quality systems
• Knowledge of spoken Spanish is a plus
• The employee must be able to lift and/or move up to 50 pounds
• While performing the duties of this job, the employee is required to use hands to finger, handle, or feel and is frequently required to stand, walk, reach with hands and arms, stoop, kneel, crouch, or crawl, and talk or hear
• The employee is required to sit, climb or balance and taste or smell
• The position requires a great deal of walking and standing, approximately 85%.

Catalent’s standard leadership competencies that are used to interview and for Performance & Development

• Leads with Integrity and Respect
• Delivers Results
• Demonstrates Business Acumen
• Fosters Collaboration and Teamwork
• Champions Change
• Engages and Inspires
• Coaches and Develops

Position Benefits

• Spearhead exciting and innovative projects
• Fast-paced, dynamic environment
• High visibility to members at all levels of the organization
• 152 hours of PTO + 8 paid holidays

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.