Technical Writer

Actalent; Kalamazoo (MI); On-site; USD 41,000 - 69,000; Full time

Benefits offered by this job

Medical, dental & vision

401(k) Retirement Plan

Health Spending Account (HSA)

Paid Time Off

Job summary

Actalent is seeking a Technical Writer for Quality Assurance Support in Kalamazoo, MI. You will support GMP documentation, investigations, deviations, and CAPAs, creating, editing, and maintaining batch records and SOPs to meet quality standards.

In this contract role, you will collaborate with the Quality, Process, and Validation teams, ensuring accuracy and clarity in documentation, while adhering to GMP requirements and industry best practices.

Qualifications

• Proven technical writing skills for clear, concise, and accurate documents in a scientific or technical context.
• Experience writing in a scientific setting, including report writing in science-related coursework or projects.
• Knowledge of GMP and its application in pharmaceutical environments.
• Experience with quality assurance activities such as investigations, deviations, and CAPAs.
• Ability to write, edit, and review batch records and SOPs in line with quality standards.
• Strong attention to detail and accuracy in documentation.

Responsibilities

• Support quality investigations and deviations with accurate documentation and timely completion.
• Assist with the development, implementation, and tracking of CAPAs arising from investigations.
• Write, edit, and review batch records to ensure clarity and compliance with GMP standards.
• Update and revise SOPs to reflect current processes and regulatory expectations.
• Perform gap analyses on documentation and processes to identify improvements.
• Collaborate with SMEs to gather information and translate it into compliant documentation.
• Ensure all materials meet pharmaceutical quality standards and GMP requirements.
• Participate in team meetings to support quality initiatives and documentation needs.

Skills

Technical writing

Scientific writing

GMP knowledge

QA investigations

Batch records

SOP development

Attention to detail

Education

Bachelor of Science in life sciences or engineering

Job description

Job Title

Technical Writer Quality Assurance Support

Job Description

This role provides critical quality assurance support to the Quality, Process, and Validation team within a pharmaceutical GMP environment. The Technical Writer focuses on quality investigations, deviations, and CAPAs while creating, editing, and maintaining high-quality batch records and standard operating procedures (SOPs) that align with established quality standards.

Responsibilities

• Support the Quality, Process, and Validation team with quality investigations and deviations, ensuring accurate documentation and timely completion.
• Support the development, implementation, and tracking of CAPAs arising from quality investigations and deviations.
• Write, edit, and review batch records to ensure clarity, accuracy, and compliance with GMP and internal quality standards.
• Update and revise SOPs to reflect current processes, regulatory expectations, and best practices.
• Perform gap analyses on documentation and processes to identify areas for improvement and alignment with quality standards.
• Collaborate with subject matter experts to gather technical information and translate it into clear, concise, and compliant documentation.
• Ensure all written materials meet pharmaceutical quality standards and adhere to GMP requirements.
• Participate in team meetings and cross-functional discussions to support quality initiatives and documentation needs.

Essential Skills

• Proven technical writing skills, with the ability to create clear, concise, and accurate scientific or technical documents.
• Experience writing in a scientific context, including report writing in science classes or other scientific arenas.
• Knowledge of GMP (Good Manufacturing Practices) and their application in a pharmaceutical environment.
• Experience with quality assurance activities such as quality investigations, deviations, and CAPAs.
• Ability to write, edit, and review batch records and SOPs in alignment with quality standards.
• Strong attention to detail and accuracy in documentation.
• Bachelor of Science degree in a life science or engineering discipline.

Additional Skills & Qualifications

• Experience working in a pharmaceutical or GMP-regulated environment.
• Familiarity with quality standards and quality assurance principles in the life sciences industry.
• Ability to perform gap analysis on documentation and processes.
• Strong written communication skills, with the ability to work effectively with subject matter experts and cross-functional teams.
• Motivation to build a long-term career in quality assurance, technical writing, or pharmaceutical operations, with interest in future growth opportunities.

Work Environment

This is an office-based role in the Rochester area, with approximately 90% of the time spent working at a computer and about 10% spent in team meetings and discussions with subject matter experts. The position follows an 8-hour shift with a 30-minute unpaid lunch, Monday through Friday, within hours of operation from 7:00 a.m. to 4:30 p.m. The environment is professional and focused on quality, collaboration, and adherence to GMP standards, offering exposure to pharmaceutical operations and opportunities for future growth.

Job Type & Location

This is a Contract position based out of Kalamazoo, MI.

Pay And Benefits

The pay range for this position is $30.00 - $50.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:

• Medical, dental & vision
• Critical Illness, Accident, and Hospital
• 401(k) Retirement Plan
• Pre-tax and Roth post-tax contributions available
• Life Insurance (Voluntary Life & AD&D for the employee and dependents)
• Short and long-term disability
• Health Spending Account (HSA)
• Transportation benefits
• Employee Assistance Program
• Time Off/Leave (PTO, Vacation or Sick Leave)

Application Deadline

This position is anticipated to close on Nov 16, 2026.

Workplace Type

This is a fully onsite position in Kalamazoo,MI.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [e-mail] for other accommodation options.

San Francisco Fair Chance Ordinance

Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI)

We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.