Technical Writer: Hybrid

Staffmark Group; Branchburg Township (NJ); Hybrid; USD 55.000 - 83.000; Vollzeit

Zusammenfassung

Staffmark Group seeks a detail-oriented Technical Writer in Branchburg, NJ for a 6-month contract with potential extension. The role centers on GMP documentation, CAPA closures, and controlled documents to support supply chain and manufacturing operations.

You will collaborate with SMEs, Quality, and Supply Chain teams to develop clear, compliant SOPs, forms, and change controls, ensuring consistency and timely delivery while meeting regulatory requirements.

Qualifikationen

• Bachelor's degree in a scientific discipline or 5+ years in a related field.
• 3–6 years of relevant experience in pharma manufacturing or a regulated industry.
• Strong technical writing skills for controlled documentation.
• Excellent written and verbal communication across all organizational levels.
• Working knowledge of GMP documentation and change management processes.

Aufgaben

• Author, review, revise, and maintain GMP documentation and CAPA closures.
• Develop documentation standards, templates, and formatting guidelines.
• Collaborate with Supply Chain to ensure consistency and reduce gaps in documentation.
• Ensure documents meet GMP requirements and internal Quality standards.
• Support CAPA closures by updating required documentation and coordinating actions.
• Coordinate document change management activities and reviews/approvals.

Kenntnisse

Technical writing

Communication

Change management

Multitasking

Process improvement

Ausbildung

Bachelor's degree in a scientific discipline

Tools

Microsoft Office (Word, Excel, Access, PowerPoint)

Jobbeschreibung

Technical Writer

6 months contract (possible extension)

Hybrid Branchburg, NJ - 3 days onsite/2 days remote

About the Opportunity

We're seeking a detail-oriented Supply Chain Technical Writer to support our client, a leading global biopharmaceutical company focused on developing innovative medicines that improve patients' lives. This role will support supply chain and manufacturing operations by developing, revising, and maintaining Good Manufacturing Practice (GMP) documentation and facilitating Corrective and Preventive Action (CAPA) closures.

The ideal candidate has experience in pharmaceutical manufacturing, technical writing, and controlled documentation processes. This individual will collaborate with subject matter experts (SMEs), Quality teams, and Supply Chain stakeholders to ensure documentation is clear, consistent, compliant, and aligned with operational requirements.

This is a six-month contract opportunity with the potential for extension, based in Branchburg, NJ, with a hybrid schedule requiring three days onsite and two days remote each week.

Key Responsibilities

• Partner with Supply Chain subject matter experts to author, review, revise, and maintain GMP documentation, including Standard Operating Procedures (SOPs), work instructions, forms, specifications, and change control documentation.
• Develop and implement documentation standards, templates, and formatting guidelines to ensure consistency, clarity, logical organization, and compliance across controlled documents.
• Collaborate with Supply Chain counterparts to align documentation practices, minimize gaps and duplication, and maintain consistency across operational processes.
• Work closely with Quality teams to ensure manufacturing and operational documentation meets applicable GMP requirements and internal quality standards.
• Support CAPA closures by developing and updating required documentation, coordinating follow-up activities, and helping ensure timely completion of corrective and preventive actions.
• Compile supporting documentation and coordinate document change management activities, ensuring all required reviews, approvals, and records are completed accurately and on schedule.
• Follow up with document reviewers and approvers to facilitate timely reviews, resolve outstanding items, and maintain project timelines.
• Coordinate with Supply Chain personnel to schedule and complete documentation-related activities in alignment with manufacturing and operational priorities.
• Participate in operational process improvement initiatives, including change planning, change proposal reviews, meeting facilitation, and the development of stakeholder communications.
• Leverage employee feedback, operational data, and cross-functional collaboration to identify documentation gaps, improve processes, and support continuous improvement initiatives.

Required Qualifications

• Bachelor's degree in a scientific discipline or a minimum of five years of equivalent relevant experience.
• Three to six years of relevant experience in pharmaceutical manufacturing or a related regulated industry.
• Strong technical writing skills, with experience developing, revising, and maintaining controlled documentation.
• Excellent written and verbal communication skills, with the ability to collaborate effectively across all levels of an organization.
• Working knowledge of GMP documentation requirements and change management processes.
• Proficiency in Microsoft Office applications, including Word, Excel, Access, and PowerPoint.
• Strong organizational skills and attention to detail, with the ability to manage multiple documentation activities and competing priorities.
• Demonstrated critical and creative thinking skills, with the ability to identify documentation gaps and recommend practical solutions.
• Experience supporting process improvement initiatives, documentation standardization, or operational efficiency efforts.

Preferred Qualifications

• Previous technical writing, training, or document control experience in a pharmaceutical manufacturing environment.
• Experience with electronic document management systems or other advanced documentation management applications.
• Familiarity with CAPA processes, change controls, and quality management systems.
• Experience facilitating cross-functional meetings, coordinating stakeholder reviews, and supporting continuous improvement initiatives.

Why Apply?

This opportunity offers the chance to contribute to critical supply chain and manufacturing operations within a leading biopharmaceutical environment. You will collaborate with cross-functional teams, strengthen GMP documentation practices, and support quality and process improvement initiatives that help maintain operational excellence.

The base pay range listed reflects what we reasonably expect to offer for this role. Actual pay may vary based on location, experience, and performance. Depending on the position, benefits may include medical, dental, and vision coverage; retirement and savings plans; paid holidays and time off; supplemental insurance; and additional wellness or incentive programs.

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Digital People is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Digital People offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Digital People is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.