Documentation Specialist

Talentify; West Sacramento (CA); On-site; USD 52,000 - 76,000; Full time

Job summary

LanceSoft is seeking a skilled Document Control Specialist in West Sacramento to develop, maintain, and manage GMP documentation. You will ensure templates, IDs, and cross-references meet established standards and facilitate efficient document control processes.

The role requires a Bachelor’s degree (or equivalent) with 3+ years in GMP environments, strong MS Word/Excel skills, and clear English communication. This on-site position offers growth within a quality-driven team.

Qualifications

• Bachelor’s degree OR a high school education and a minimum of 3 years experience in a GMP controlled environment.
• Experience using document control strategies or methods in a GMP controlled environment.
• Knowledge of MS Office products as well as the ability to learn new systems as required.
• Ability to communicate using English.
• Prior experience using word processing, spreadsheet, and presentation software.

Responsibilities

• Distributing controlled documents (procedures, specs) to the Production floor and other points of use.
• Sorting, filing, and maintaining controlled documents and other Quality Records (e.g. TRVs, DHRs) in Document Control room.
• When necessary, coordinate off-site storage activities.
• Process requests for copies of controlled documents and Quality Records.

Skills

Document control

MS Office

English communication

Attention to detail

Cross-functional collaboration

Education

Bachelor's degree in a related field

High school diploma with GMP experience

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Enter Job Description...

Develops, produces, and maintains a variety of complex technical and user documentation. Plans and executes writing projects that need attention to complex technical content. Provides effective and useful presentation of that content, and timely reporting of progress in meeting schedule milestones. Complex knowledge and utilization of one or more word processing tools.

Job Qualifications: Ability to determine project requirements, perform complex writing, copy editing, technical editing and documentation design activities. Ability to create document structure and graphics at project level. Must have good writing skills. The ability to write consistent and clear documentation with the goal of explaining complex information simply and accurately.

Education and Experience: Bachelor's degree and 3-5 years experience or equivalent

Key responsibilities include:

• Ensuring that document reviews and approvals are managed in an efficient and effective manner.
• Ensuring that all records of document status, outstanding change controls, document reviews, and document approvals are meticulously maintained.
• Ensuring that documents comply with established templates, formats, and identification naming numbering standards.
• Ensuring that document cross-references are accurate and traceable.
• Maintaining the electronic document library and developing and or maintaining a QMS document inventory that includes relevant information regarding document identification, status, effective dating and other pertinent document control information, as required.
• Managing and controlling specific quality records, as required.
• Distributing and removing controlled documentation to from points of use, as required.

Qualifications:

1. Bachelor’s degree OR a high school education and a minimum of 3 years experience in a GMP controlled environment.
2. Experience using document control strategies or methods in a GMP controlled environment.
3. Knowledge of MS Office products as well as the ability to learn new systems as required.
4. Ability to communicate using English.
5. Prior experience using word processing, spreadsheet, and presentation software.

Essential Functions (Responsibilities):

• Distributing controlled documents (procedures, specs) to the Production floor and other points of use.
• Sorting, filing, and maintaining controlled documents and other Quality Records (e.g. TRVs, DHRs) in Document Control room.
• When necessary, coordinate off-site storage activities.
• Process requests for copies of controlled documents and Quality Records.

Qualifications/Requirements: (Basic Qualifications):

• Must have a high school diploma and previous experience with filing.
• Must be able to lift up to 30lbs and perform physical labor (moving boxes containing documents, bending over to file documents).
• Basic knowledge of Microsoft Word and Excel.
• Associates degree OR a high school diploma and a minimum of 2 years experience in a document control/administrative role.
• Self-starter with the ability to learn quickly and require minimal supervision.
• Attention to detail, great organizational skills.
• Individual who is energizing, passionate, and results/customer oriented.
• Excellent communication skills: interpersonal, oral and written.
• Ability to work in a fast-paced environment, meet simultaneous deadlines, and remain flexible.
• Ability to work on cross-functional teams and with various departments.

EEO Employer

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.