H-1B Visa Documentation Specialist Jobs
Documentation Specialists qualify for H-1B visa sponsorship when the role requires a bachelor's degree in a directly related field, technical writing, information science, or a discipline tied to the employer's industry. Many sponsors file under SOC code 27-3042, and LCA prevailing wage levels vary by region and employer size.
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Get Access To All JobsJob title: Documentation Specialist I
Location: Pearl River, NY (Onsite)
Schedule: Monday - Friday; 7:30 AM - 4:00 PM
Pay Rate Max: $37 per hour
Sanofi's contingent workforce program, FLEXT Direct, is seeking a Documentation Specialist I for a 6-month contract.
We are seeking a highly detail-oriented and motivated professional to join our quality assurance team in a dynamic pharmaceutical or biotechnology manufacturing environment. This role plays a critical part in ensuring that all manufacturing batch records are thoroughly reviewed and compliant with regulatory requirements, while also serving as a key resource for coaching and guiding shopfloor technicians on Good Documentation Practices (GDP). The ideal candidate will bring a strong sense of urgency, exceptional interpersonal skills, and a commitment to maintaining the highest standards of drug substance safety, efficacy, and quality. This position offers the opportunity to contribute meaningfully to process improvements, deviation investigations, and corrective action initiatives that directly impact product quality and patient safety.
Responsibilities:
- Track and review manufacturing batch records to ensure compliance with regulatory requirements
- Follow up with Manufacturing Technicians to ensure corrections are completed in a timely manner
- Maintain error tracking metrics to identify and address repeated violations of GDP
- Coach shopfloor technicians on GDP principles and best practices as applicable
- Identify and escalate GDP issues that could affect the safety, efficacy, and quality of drug substance
- Review batch record structure and recommend simplifications to minimize errors as applicable
- Ensure batch record review cycle times are met consistently
- Participate in deviation investigations and CAPA creation as applicable
Skills:
- Strong experience with CAPA processes, batch record review, and technical writing
- Proficiency in using documentation and quality management systems to locate errors and manage change action requirements
- Familiarity with ERP systems and electronic documentation platforms
- Knowledge of quality systems and GDP requirements within a pharmaceutical or biotechnology setting
- Excellent attention to detail with the ability to work quickly and accurately under pressure
- Strong interpersonal and information-gathering skills with the ability to work effectively in a team environment
- Preferred experience with manufacturing GDP practices
- Preferred experience handling deviation investigations
Experience:
- Pharmaceutical or biotechnology industry experience is required
- Experience with CAPA processes, batch record review, and technical writing is required
- Experience using documentation systems and quality management platforms is required
Qualifications:
- High School Diploma with a minimum of 5 years of relevant experience, or
- Associate's Degree with a minimum of 3 years of relevant experience, or
- Bachelor's Degree with a minimum of 1 year of relevant experience, including final batch record review
Joining this team means becoming an integral part of a mission-driven organization where your contributions directly support the production of safe and effective therapies for patients. You will have the opportunity to grow your expertise in quality assurance, collaborate with cross-functional teams, and make a tangible impact on manufacturing excellence in a fast-paced and rewarding environment.
Job title: Documentation Specialist I
Location: Pearl River, NY (Onsite)
Schedule: Monday - Friday; 7:30 AM - 4:00 PM
Pay Rate Max: $37 per hour
Sanofi's contingent workforce program, FLEXT Direct, is seeking a Documentation Specialist I for a 6-month contract.
We are seeking a highly detail-oriented and motivated professional to join our quality assurance team in a dynamic pharmaceutical or biotechnology manufacturing environment. This role plays a critical part in ensuring that all manufacturing batch records are thoroughly reviewed and compliant with regulatory requirements, while also serving as a key resource for coaching and guiding shopfloor technicians on Good Documentation Practices (GDP). The ideal candidate will bring a strong sense of urgency, exceptional interpersonal skills, and a commitment to maintaining the highest standards of drug substance safety, efficacy, and quality. This position offers the opportunity to contribute meaningfully to process improvements, deviation investigations, and corrective action initiatives that directly impact product quality and patient safety.
Responsibilities:
- Track and review manufacturing batch records to ensure compliance with regulatory requirements
- Follow up with Manufacturing Technicians to ensure corrections are completed in a timely manner
- Maintain error tracking metrics to identify and address repeated violations of GDP
- Coach shopfloor technicians on GDP principles and best practices as applicable
- Identify and escalate GDP issues that could affect the safety, efficacy, and quality of drug substance
- Review batch record structure and recommend simplifications to minimize errors as applicable
- Ensure batch record review cycle times are met consistently
- Participate in deviation investigations and CAPA creation as applicable
Skills:
- Strong experience with CAPA processes, batch record review, and technical writing
- Proficiency in using documentation and quality management systems to locate errors and manage change action requirements
- Familiarity with ERP systems and electronic documentation platforms
- Knowledge of quality systems and GDP requirements within a pharmaceutical or biotechnology setting
- Excellent attention to detail with the ability to work quickly and accurately under pressure
- Strong interpersonal and information-gathering skills with the ability to work effectively in a team environment
- Preferred experience with manufacturing GDP practices
- Preferred experience handling deviation investigations
Experience:
- Pharmaceutical or biotechnology industry experience is required
- Experience with CAPA processes, batch record review, and technical writing is required
- Experience using documentation systems and quality management platforms is required
Qualifications:
- High School Diploma with a minimum of 5 years of relevant experience, or
- Associate's Degree with a minimum of 3 years of relevant experience, or
- Bachelor's Degree with a minimum of 1 year of relevant experience, including final batch record review
Joining this team means becoming an integral part of a mission-driven organization where your contributions directly support the production of safe and effective therapies for patients. You will have the opportunity to grow your expertise in quality assurance, collaborate with cross-functional teams, and make a tangible impact on manufacturing excellence in a fast-paced and rewarding environment.
See all 69+ H-1B Visa Documentation Specialist Jobs
Sign up for free to unlock all listings, filter by visa type, and get alerts for new H-1B Visa Documentation Specialist Jobs.
Get Access To All JobsTips for Finding H-1B Visa Sponsorship as a Documentation Specialist
Align your degree to the role
USCIS requires your degree to directly relate to the Documentation Specialist position, not just any bachelor's degree. A degree in technical communication, English, or a field matching the employer's industry strengthens your specialty occupation case significantly.
Search LCA filings by occupation code
Use Migrate Mate to filter Documentation Specialist openings by employers who've filed LCAs under SOC 27-3042. This surfaces companies with verified H-1B sponsorship history for this exact role, not just general sponsorship willingness.
Confirm the job posting requires a degree
H-1B approval depends on the role being a specialty occupation. If a job listing says 'bachelor's preferred' rather than 'required,' that posting may not support your petition. Target employers whose job descriptions state a specific degree as a minimum requirement.
Check prevailing wage before negotiating
Your employer's LCA must certify a wage at or above DOL's prevailing rate for Documentation Specialists in that metro area. Run your target location and SOC code through the OFLC Wage Search before your offer conversation so you know the floor.
Time your application around the cap calendar
H-1B cap-subject petitions open April 1 for an October 1 start date. If you're on OPT, confirm your EAD expiration relative to that timeline and ask your employer early whether they'll file in the regular or premium processing track.
Build a portfolio that proves specialty occupation
Document your work samples by industry and technical domain before your petition is filed. USCIS may issue an RFE questioning whether Documentation Specialist is a specialty occupation; a portfolio tying your degree field to complex documentation outputs strengthens your employer's response.
H-1B Visa Documentation Specialist: Frequently Asked Questions
Does a Documentation Specialist role qualify as a specialty occupation for H-1B purposes?
It depends on how the employer defines the position. USCIS evaluates specialty occupation on a case-by-case basis. A Documentation Specialist role qualifies when the employer requires at least a bachelor's degree in a specific field such as technical writing, information science, or a discipline tied to the product or industry. Generic postings that accept any degree are more likely to draw an RFE.
Which SOC code do employers typically use when filing an H-1B LCA for this role?
Most employers file Documentation Specialist roles under SOC code 27-3042, which covers Technical Writers. Some employers in highly regulated industries file under adjacent codes depending on the role's primary function. You can verify which code an employer used for past LCA filings and review the wage levels tied to each code using the OFLC Wage Search before accepting an offer.
How do I find employers who have actually sponsored H-1B visas for Documentation Specialists?
Migrate Mate filters job listings by verified LCA filing history, so you can identify employers who have filed H-1B petitions for Documentation Specialist or Technical Writer roles specifically. This is more reliable than asking employers cold, since DOL LCA disclosure data shows actual filing activity by occupation code and employer.
Can I transfer my H-1B to a new Documentation Specialist employer mid-year?
Yes. Under H-1B portability rules, you can start working for a new employer as soon as they file a transfer petition with USCIS, without waiting for approval. The new employer still needs to file an LCA and I-129, and the role must remain a qualifying specialty occupation. You don't have to wait for the cap or a new fiscal year.
What happens to my H-1B if my Documentation Specialist contract ends before the petition expires?
You have a 60-day grace period after your employment ends to find a new sponsoring employer, change status, or depart the U.S. During that window you aren't authorized to work, but you can remain in the country while pursuing options. Filing a transfer petition within that period preserves your status while the new petition is pending.