Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. T he Role * Review, issuance, and ...
Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve difficult development and manufacturing challenges. T he Role * Review, issuance, and ...
Technician I Staging - Supply Chain
Madison, WI · On-site
$42K - $51K/yr
Sunday - Wednesday, 2pm-12am * 100% on-site (Madison, WI) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features ...
Technician I Staging - Supply Chain
Madison, WI · On-site
$42K - $51K/yr
Sunday - Wednesday, 2pm-12am * 100% on-site (Madison, WI) Catalent, Inc. is a leading global Contract Development and Manufacturing Organization (CDMO). Located in Madison, WI, this facility features ...
Catalent Pharma Solutions in Madison, WI is hiring a Scientist I, Quality Control. The Quality Control (QC) team is responsible for testing products, raw materials and the manufacturing environment ...
Catalent Pharma Solutions in Madison, WI is hiring a Scientist I, Quality Control. The Quality Control (QC) team is responsible for testing products, raw materials and the manufacturing environment ...
Development Scientist I
Greenville, NC · On-site
Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial ...
Development Scientist I
Greenville, NC · On-site
Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated formulation development, analytical services, commercial ...
Monday - Friday, 8:00am to 5:00pm * 100% on-site The Morrisville (MSV) facility is Catalent's center of excellence for nasal product development and manufacturing, providing end-to-end services from ...
Monday - Friday, 8:00am to 5:00pm * 100% on-site The Morrisville (MSV) facility is Catalent's center of excellence for nasal product development and manufacturing, providing end-to-end services from ...
M-F 8am-5pm * 100% on-site Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic ...
M-F 8am-5pm * 100% on-site Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative technologies and solutions to help more and better biologic ...
Sr. Social Media Specialist
Tampa, FL · On-site
Onsite based out of our Tampa, FL location The Senior Social Media Specialist will elevate Catalent's brand credibility, and commercial pipeline influence through strategic, insight-driven social ...
Sr. Social Media Specialist
Tampa, FL · On-site
Onsite based out of our Tampa, FL location The Senior Social Media Specialist will elevate Catalent's brand credibility, and commercial pipeline influence through strategic, insight-driven social ...
Microbiologist I
Greenville, NC · On-site
Monday-Friday, Days. * 100% based on-site in Greenville, NC Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated ...
Microbiologist I
Greenville, NC · On-site
Monday-Friday, Days. * 100% based on-site in Greenville, NC Catalent's Greenville, N.C. facility specializes in end-to-end turn-key solutions for oral solid dosage forms, including integrated ...
Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast growing business, backed by a global public company. People joining our ...
Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast growing business, backed by a global public company. People joining our ...
Senior Program Manager - Program Management
Madison, WI · On-site
$116K - $117K/yr
Catalent Biologics is making significant investments in people and capabilities. This is a unique opportunity to join a small, fast-growing business, backed by a global public company. People joining ...
Senior Program Manager - Program Management
Madison, WI · On-site
$116K - $117K/yr
Catalent Biologics is making significant investments in people and capabilities. This is a unique opportunity to join a small, fast-growing business, backed by a global public company. People joining ...
Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast growing business, backed by a global public company. People joining our ...
Catalent Biologics is making significant investments in people and capabilities. This is a unique opening to join a small, fast growing business, backed by a global public company. People joining our ...
Catalent Pharma Solutions in Kansas City, MO is hiring a Pharmaceutical Development Scientist I. The Kansas City Pharmaceutical Development Scientist I serve as technical representative for ...
Catalent Pharma Solutions in Kansas City, MO is hiring a Pharmaceutical Development Scientist I. The Kansas City Pharmaceutical Development Scientist I serve as technical representative for ...
Monday - Friday 8am-5pm * 100% on-site Catalent's Kansas City facility is a leading center for integrated development, manufacturing, and packaging services for oral solid dosage forms. The site ...
Monday - Friday 8am-5pm * 100% on-site Catalent's Kansas City facility is a leading center for integrated development, manufacturing, and packaging services for oral solid dosage forms. The site ...
Facilities Engineer
Winchester, KY · On-site
Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product ...
Facilities Engineer
Winchester, KY · On-site
Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product ...
Monday-Friday, Standard Hours * 100% on-site Join Catalent's flagship softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion ...
Monday-Friday, Standard Hours * 100% on-site Join Catalent's flagship softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion ...
Warehouse Group Lead
Winchester, KY · On-site
$15.75 - $20/hr
Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product ...
Warehouse Group Lead
Winchester, KY · On-site
$15.75 - $20/hr
Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product ...
Quality Control Analyst
Winchester, KY · On-site
$20.75 - $27.75/hr
Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product ...
Quality Control Analyst
Winchester, KY · On-site
$20.75 - $27.75/hr
Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product ...
Quality Engineer I, Biologics Analytical Services
Kansas City, MO · On-site
$70K - $90K/yr
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 ...
Quality Engineer I, Biologics Analytical Services
Kansas City, MO · On-site
$70K - $90K/yr
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 ...
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 ...
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 ...
Join Catalent's flagship Softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive ...
Join Catalent's flagship Softgel development and manufacturing facility in North America, located in St. Petersburg, FL, with a capacity of 18 billion capsules per year. This role offers competitive ...
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Documentation Specialist, Analytical Research & Development
Catalent, Inc.Saint Petersburg, FL • On-site
Full-time
Life, PTO
Posted 2 days ago
Catalent rating
7.7
Based on 49 frontline employees who took The Breakroom Quiz
45th of 71 rated pharmaceutical
Job description
The Documentation Specialist, AR&D is responsible for reviewing, implementing and maintaining change control to quality documentation per applicable SOPs. The primary tasks performed by this individual will include managing, maintaining, writing, and issuing standard operating procedures, standard test procedures, specifications, analytical methods, and other quality documents.
Position Summary
This position is 100% on-site at the St. Petersburg site.
Shift: Monday - Friday 8 am - 5 pm hours
St. Petersburg is our primary Softgel 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.
The Role
- Review, issuance, and closure of Document Change Requests (DCRs) in accordance with Catalent's SOPs for all quality documents (i.e.SOPs, Methods, Specifications, etc.) Authoring and modifying SOPs with input from the change initiators.
- Compiling and Reviewing all documents associated with new material qualification.
- Maintenance of the Document Change Request database; Maintenance of Quality Assurance files for Document Change Requests.
- Conducting lifecycle management of quality documents within Documentum.
- Printing, binding, and distribution of controlled logbooks for all departments; Assists in the preparation for and facilitation of regulatory and customer audits.
- Serves on site project teams. Interfaces with Engineering, Procurement, Quality Control, Quality Assurance, Process Development, Project Managers, Validation and Manufacturing management in support of providing documentation support for new product introductions and for changes to existing products; Ensures that peers and supervisors are informed as to the QA issues that may arise in the projects that may affect progress.
- Other duties as assigned.
The Candidate
- Requires a Bachelor's degree in a relevant business discipline, technical background in chemistry is preferred.
- Requires a minimum of three years' experience with documentation systems, at least one year in the pharmaceutical industry. Solid understanding of cGMPs as they apply to documentation systems.
- Direct, hands-on experience with electronic documentation systems; knowledge of Documentum is preferred. Knowledge of LIMS systems, familiarity with bar-coding systems, finished goods label generation, POMS weigh and dispense applications, TrackWise, and JDE is a plus.
- Proficient technical writing skills are required.
- Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds. 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 Work At Catalent
- 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.
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.
About Catalent
Sourced by ZipRecruiter
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.
Industry
Pharmaceutical product wholesalers
Company size
10,000+ Employees
Headquarters location
Somerset, NJ, US
Year founded
2007