Sr. QA Specialist, Operations

Job Title:                       Sr. QA Specialist, Operations

City:                                 Chelsea

State:                                MA

JOB DESCRIPTION:

Perform various quality assurance checks during all manufacturing processes; Assess regulatory and quality risks in manufacturing activities and processes according to regulatory agency rules and guidelines; Conduct quality audits of manufacturing processes and finished products; Investigate and resolve quality issues and determine any deviations from established procedures; Monitor and analyze quality data to identify trends and opportunities for improvement; Maintain and update quality documentation and records; Provide oversight of production activities including monitoring use of complex equipment; Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA and international guidelines; Analyze and identify root causes for production and quality control issues and implement corrective actions; and Monitor all equipment used for manufacturing to assure quality of final products.

EDUCATION AND EXPERIENCE: Requires a Bachelor’s degree in Drug Regulatory Affairs and 4 years of experience in job offered or 4 years of experience in Related Occupation

RELATED OCCUPATION:

Senior Quality Assurance Specialist or any other job title performing the following job duties:

Assess regulatory and quality risks in manufacturing activities and processes according to regulatory agency rules and guidelines; Investigate and resolve quality issues and determine any deviations from established procedures; Monitor and analyze quality data to identify trends and opportunities for improvement; Maintain and update quality documentation and records; Assist with protocol and implement validation procedures in accordance with Quality System Regulations (QSR), FDA and international guidelines; and Analyze and identify root causes for production and quality control issues and implement corrective actions.

JOB TIME:                          Full Time

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. 

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 [email protected]. 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 [email protected] for us to investigate with local authorities.

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