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Manufacturing Documentation Specialist Jobs (NOW HIRING)

Genovice

QA Documentation Specialist

San Diego, CA

$50 - $60/hr

Pharmaceutical Manufacturing Position Overview Our client is seeking a QA Documentation Specialist to support the development, revision, and review of GMP manufacturing documentation. The ideal ...

New

Cipla

$66K - $86K/yr

The Manufacturing Documentation Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOP's. In this role the Documentation Specialist ...

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How much do manufacturing documentation specialist jobs pay per hour?

As of Aug 24, 2026, the average hourly pay for manufacturing documentation specialist in the United States is $24.23, according to ZipRecruiter salary data. Most workers in this role earn between $18.27 and $27.40 per hour, depending on experience, location, and employer.

What is a manufacturing documentation specialist?

A Manufacturing Documentation Specialist is responsible for creating, reviewing, and managing production-related documents to ensure compliance with quality and regulatory standards. They maintain standard operating procedures (SOPs), work instructions, and batch records to support efficient manufacturing processes. Their role involves collaborating with various departments, including quality assurance and production teams, to ensure accurate documentation and process improvements. Strong attention to detail, knowledge of industry regulations, and proficiency in document control systems are essential for this role.

What are the key skills and qualifications needed to thrive as a manufacturing documentation specialist?

A Manufacturing Documentation Specialist should have a strong understanding of manufacturing processes, document control, and quality standards, often supported by a relevant degree or technical background. Familiarity with document management systems (DMS), quality management systems (QMS), and regulatory compliance tools like ISO or GMP is highly valued. Excellent organizational skills, attention to detail, and effective communication enable specialists to coordinate with cross-functional teams and maintain accurate records. These competencies ensure compliance, support process efficiency, and help maintain high-quality standards in a manufacturing environment.

What are the main challenges that manufacturing documentation specialists typically face in their role?

One of the main challenges Manufacturing Documentation Specialists face is ensuring documentation accuracy and compliance while working under tight deadlines in a dynamic manufacturing environment. They often need to coordinate with multiple departments—such as engineering, quality assurance, and production—to gather information and ensure that all documents reflect the latest processes and regulatory requirements. Staying organized and keeping up with frequent updates or revisions to procedures can be demanding. However, successfully meeting these challenges helps maintain smooth operations and supports the company's overall commitment to quality and regulatory compliance.

What does a manufacturing documentation specialist do?

A manufacturing documentation specialist creates, manages, and maintains technical documents such as work instructions, procedures, and quality records to ensure accurate communication of manufacturing processes. They often use document control software and collaborate with engineering and production teams to ensure compliance with industry standards. Attention to detail and knowledge of manufacturing operations are essential for this role.

What is documentation in manufacturing?

In manufacturing, documentation refers to the detailed records, manuals, procedures, and specifications that describe the production processes, quality standards, and compliance requirements. A Manufacturing Documentation Specialist ensures these documents are accurate, up-to-date, and accessible to support quality control, regulatory compliance, and efficient operations.

What skills do you need to be a manufacturing documentation specialist?

A manufacturing documentation specialist needs strong attention to detail, excellent written and verbal communication skills, and proficiency with document management software and technical writing tools. Knowledge of manufacturing processes, quality standards, and basic understanding of engineering or technical drawings are also important for creating accurate and compliant documentation.
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Manufacturing Documentation Specialist jobs near you
Infographic showing various Manufacturing Documentation Specialist job openings in the United States as of August 2026, with employment types broken down into 93% Full Time, and 7% Contract. Highlights an 100% In-person job distribution, with an average salary of $50,388 per year, or $24.2 per hour.

Manufacturing Documentation Specialist

Nashville, TN • On-site

August Bioservices
Pharmaceutical and Medicine Manufacturing • 51 - 200 employees
Learn more about August Bioservicesexternal

Full-time

Re-posted 9 days ago

Job description

Headquartered in Nashville, TN - one of the fastest-growing and most exciting cities in the United States - August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project - including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!
The Manufacturing Documentation Specialist supports GMP manufacturing by performing detailed review of batch production records and driving corrections. This role plays a critical part in ensuring accurate, compliant, and timely batch record review activities in support of batch disposition and release.
The Manufacturing Documentation Specialist collaborates closely with Manufacturing, Quality, and other cross-functional teams to ensure documentation accuracy, data integrity, and compliance with current Good Manufacturing Practices (cGMP) and applicable regulatory requirements. This position also supports record release, continuous improvement and inspection readiness activities within a fast-paced, regulated manufacturing environment.
ESSENTIAL DUTIES & RESPONSIBILITIES
  • Review executed batch production records to support batch disposition and release activities.

  • Identify and drive continuous improvements to GDP through record enhancements.

  • Track GDP performance and record release timing through sitewide metrics.
  • Participate in on the floor real-time review

  • Create, revise, proofread, format, and merge GMP documentation, including SOPs, batch records, and logbooks in support of site operations.

  • Support Manufacturing on the Floor by assisting with documentation review, clarification of GMP requirements, and real-time support.

  • Ensure adherence to company policies, procedures, and applicable regulatory requirements, including FDA, ICH, and global GMP standards.

  • Support client audits and regulatory inspections by FDA and other regulatory agencies, including preparation and retrieval of documentation.

  • Communicate effectively with cross-functional teams to resolve documentation issues and support timely completion of quality activities.

QUALIFICATIONS
  • Bachelor of Science degree in Life Sciences, or a related discipline required, or an equivalent combination of education and relevant experience.

  • Minimum of two (2) to three (3) years of experience working in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment required.

  • Minimum of two (2) years of direct experience performing batch record review activities required.

KNOWLEDGE, SKILLS, & ABILITIES
  • Working knowledge of cGMP requirements, including 21 CFR Parts 210, 211, 820, and familiarity with PIC/S Guide to Good Manufacturing Practice Parts I and II or EU GMP guidelines, including Annex 1.

  • Knowledge of FDA Guidance on Aseptic Processing and 21 CFR Part 11 electronic records and signatures requirements preferred.

  • Proficiency in electronic quality management systems, including MasterControl or equivalent platforms.

  • Strong attention to detail and documentation accuracy, with the ability to identify errors, inconsistencies, and compliance gaps.

  • Excellent organizational and time management skills, with the ability to prioritize multiple tasks in a fast-paced environment.

  • Strong written and verbal communication skills, with the ability to communicate clearly and professionally with cross-functional teams.

  • Ability to work independently while maintaining accountability to quality standards, timelines, and procedures.

  • Demonstrated commitment to data integrity, compliance, and continuous improvement.

PHYSICAL REQUIREMENTS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
  • Ability to perform all required gowning.
  • Ability to work in an office and manufacturing environment, including time spent on the production floor as needed.

  • Ability to sit or stand for extended periods while reviewing documentation and working at a computer.

  • Ability to use standard office equipment, including computers, printers, and scanners.

  • Ability to lift and carry materials or files up to 20 pounds, with or without reasonable accommodation.

  • Ability to wear required personal protective equipment (PPE) when supporting activities in manufacturing areas.

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule - from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.
We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!
August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.
We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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