OPT Documentation Specialist Jobs
Documentation Specialist roles involve creating, managing, and maintaining technical documents, user guides, and compliance records. Many employers hire on OPT, particularly in tech, healthcare, and regulated industries where clear documentation is critical. Your STEM OPT extension eligibility depends on whether the role is housed in a STEM-designated program.
See All OPT Documentation Specialist JobsOverview
Showing 5 of 53+ Documentation Specialist jobs
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
Have you applied for this role?
See all 53+ Documentation Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new Documentation Specialist roles.
Get Access To All JobsDocumentation Specialist, Analytical Research & Development
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.
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.
Documentation Specialist, Analytical Research & Development
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.
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.
See all 53+ OPT Documentation Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new OPT Documentation Specialist Jobs.
Get Access To All JobsTips for Finding OPT Sponsorship as a Documentation Specialist
Highlight technical writing tools in your resume
Employers hiring Documentation Specialists want to see specific tools upfront. List experience with platforms like Confluence, MadCap Flare, or Adobe FrameMaker. Candidates who name tools get screened in faster than those who only describe documentation experience in general terms.
Clarify your OPT timeline early in outreach
Documentation roles often involve onboarding ramps of 30 to 60 days. Let hiring managers know your OPT start date and remaining authorization window upfront so they can plan accordingly. Removing ambiguity early prevents late-stage rejections over timing concerns.
Target industries with heavy compliance requirements
Regulated sectors like medical devices, pharmaceuticals, and financial services require extensive documentation by law. These employers hire Documentation Specialists consistently, often under OPT, because documentation backlogs are costly. Your authorization status is rarely a barrier in these environments.
Quantify the scope of your documentation work
Vague resume entries like 'created documentation' are easy to overlook. Instead, specify volume and impact: number of documents maintained, user bases served, or error rates reduced. Concrete numbers make your experience credible and easier for non-technical hiring managers to evaluate.
Emphasize cross-functional collaboration experience
Documentation Specialists routinely work with engineers, product managers, and compliance teams. Employers want someone who can extract accurate information from subject matter experts and translate it clearly. Highlighting this collaboration in your cover letter addresses a common hiring concern directly.
Understand whether your degree qualifies for STEM OPT extension
If your degree is in computer science, information systems, or a related STEM field, your OPT may extend to 36 months total. Confirming this with your DSO before interviews lets you communicate a longer authorization window, which meaningfully reduces employer hesitation.
Documentation Specialist OPT: Frequently Asked Questions
Can I work as a Documentation Specialist on OPT without employer sponsorship?
Yes. OPT is your own work authorization, so you can accept any full-time Documentation Specialist role without the employer filing a visa petition on your behalf. The employer does not need to sponsor you during the OPT period. Sponsorship only becomes relevant if they want to keep you on after your OPT expires, typically through an H-1B visa petition.
Does a Documentation Specialist role qualify for STEM OPT extension?
It depends on your degree, not the job title. If you graduated from a STEM-designated program, such as computer science, information science, or technical communication classified under a STEM CIP code, you may qualify for a 24-month STEM OPT extension. Confirm your degree's CIP code with your DSO before making any assumptions about your authorization window.
What should I tell employers about my OPT work authorization during the interview process?
Be straightforward: explain that you're authorized to work full time on OPT and state your authorization end date. If you're eligible for a STEM extension, mention that too, since it gives the employer a longer runway before any H-1B decision is needed. Most Documentation Specialist hiring managers are familiar with OPT and appreciate clarity over ambiguity.
Where can I find Documentation Specialist jobs that are open to OPT candidates?
Migrate Mate is built specifically for F-1 OPT students and filters for employers who actively hire international candidates. Searching on Migrate Mate lets you focus on Documentation Specialist roles where your authorization status is already understood, rather than spending time on applications where OPT gets screened out at the HR level.
Are Documentation Specialist roles typically full-time, and does that matter for OPT compliance?
Most Documentation Specialist positions are full-time, which aligns with OPT requirements. On post-completion OPT, you must work at least 20 hours per week in a role directly related to your degree field. Part-time contract roles can count if they meet the 20-hour threshold, but full-time employment is the cleaner path to maintaining valid OPT status and avoiding gaps in your record.