Quality Assurance Specialist Ii Night Shift

Quality Assurance Specialist II
Greendale is one of Catalent's gummy technology development and manufacturing facilities in North America. The site manufactures organic and vegan-based nutraceuticals via confection to enhance wellness for all consumers. Simply put - we make healthy gummies. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges.
Position Summary:
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.
Shift: Third (10 PM-6:30 AM)
The Role:

• Conduct MCS verifications
• Monitor changeover activities and be able to resolve issues of varying complexity
• Conduct thorough and detailed quality audits ensure products meet established quality standards.
• Communicate any deviations to the appropriate parties promptly.
• Audit paperwork of operators to ensure they are meeting quality standards
• Conduct PCQI documentation review.
• Responsible for holding products that are not meeting company quality standards and provide the appropriate dispositions.
• Other duties as assigned.

The Candidate:

• This position requires BS in Food Science and/or related major or have High School diploma with significant experience in manufacturing - HACCP, PCQI, GFSI, cGMP
• For business and safety reasons, must be able to communicate effectively verbally and in written English.
• Ability to communicate with all line level positions and management
• Self starter and must be able to work independently with minimum supervision
• 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

Physical Requirements:
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

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

Why you should join Catalent:

• Diverse, inclusive culture
• Competitive salary
• 401(k) retirement savings plan with company match
• Educational assistance/reimbursement
• 19 days paid time off
• Medical, dental, and vision insurance
• Life insurance
• Fitness center and wellness programs
• Flexible spending account
• Employee discount programs
• Robust employee referral program

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.
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