Overview
QA Computer Systems Specialist Jobs in Waltham, MA at Ardelyx
Quality Assurance Documentation Specialist
Position Summary
St. Petersburg is our primary soft gel development and manufacturing facility in North America with capacity of 18 billion capsules per year. Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee.
The Quality Assurance Documentation Specialist is responsible for reviewing, implementing and maintaining change control to quality documentation and electronic systems such as the electronic batch record system and electronic weigh and dispense system per applicable SOPs. The primary tasks performed by this individual will include managing, maintaining, writing, and issuing standard operating procedures, batch records, standard test procedures, specifications, analytical methods, other quality documents, and writing and maintaining computerized system recipes. To accomplish these responsibilities, as the Quality Assurance Documentation Specialist, it requires experience and understanding of document change control procedures, computer systems, and philosophies within a cGMP environment.
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
The Role
Review, issuance, and closure of Document Change Requests (DCRs) in accordance with Catalent’s SOPs for all quality documents (i.e. Engineering Drawings, SOPs, Methods, Model Work Orders, methods, etc.).
Maintenance of the Document Change Request database.
Maintenance of Quality Assurance files for Document Change Requests.
Conducting lifecycle management of quality documents within Documentum and computerized systems such as IPC and POMS.
Conducting controlled copy printing of master batch records for the production floor.
Serves on site project teams. Interfaces with Engineering, Product Development, IPC and POMS
Administrators, Quality Control, Technical Services, Validation and Manufacturing management in support of providing documentation support for new product introductions, changes to existing products, and site projects.
Support Product Development/Technical Services/ Engineering/Quality Control/Validation/Manufacturing schedules in accordance with customer and internal project commitments to minimize disruption of the project and provide documentation in support of business needs.
All other duties as assigned.
The Candidate
Requires a Bachelor’s degree in a relevant business discipline or equivalent experience, or applicable combination. A technical background and/or degree in a science (including computer science) is preferred.
A minimum of 3 years’ experience with documentation systems is preferred (authoring documents in the systems and maintaining the systems), at least 1 year in the pharmaceutical industry is preferred.
A minimum of 1 year authoring electronic batch record recipes is preferred.
Understanding of cGMPs as they apply to documentation systems.
A minimum of 1 year of experience authoring electronic batch record recipes is preferred.
Direct, hands-on experience with electronic documentation systems (authoring documents in the systems and maintaining the systems); knowledge of Documentum is preferred. Knowledge of LIMS, finished goods label generation, electronic batch record systems, POMS weigh and dispense applications, and JDE is a plus. Proficiency using computer to create and revise batch records (including in electronic batch record systems) is preferred.
Individual may be required to sit for long periods of time, while reading or preparing documents.
Ability to work effectively under pressure with constantly changing priorities and deadlines.
Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Ability to access and move throughout laboratory, production area(s) and office area(s) and use the proper safety precautions as required. Ability to use required office equipment.
Specific vision requirements include reading of written documents and use of computer monitor screen frequently.
Why You Should Join Catalent
Competitive medical benefits and 401K
152 hours of PTO + 8 Paid Holidays
Dynamic, fast-paced work environment
Opportunity to work on Continuous Improvement Processes
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.
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Title: QA Computer Systems Specialist
Company: Ardelyx
Location: Waltham, MA
