Document Control Associate

Insight Global; Beverly (MA); Sur place; USD 43 000 - 54 000; Plein temps

Avantages offerts par ce poste

Medical, dental, vision insurance

401(k) after 90 days

Paid sick leave and PTO

Résumé du poste

Insight Global is seeking a Document Control Associate to support rebuilding its quality documentation processes. You will manage controlled documents, run change orders, and ensure SOPs and forms align with quality procedures.

You will also identify process improvements and own the lifecycle of documentation from creation to archiving. The ideal candidate has 2–4 years in document control within regulated manufacturing, with experience in eDMS/eQMS, ECOs, revisions, and approvals.

Qualifications

• 2–4 years document control experience in regulated manufacturing (medical device, biopharma, pharma).
• Experience with eDMS/eQMS and ECOs/change orders including revisions, approvals, releases, and lifecycle.
• Independent mindset to identify problems and improve documentation processes.
• ISO 13485 knowledge and CAPA/audit experience preferred.
• Technical writing experience.

Responsabilités

• Manage controlled documentation within a document management system; run change orders and ensure SOPs, work instructions, specs, forms, and product docs follow quality procedures.
• Evaluate current processes and own improvements to how documentation is created, reviewed, approved, revised, distributed, and archived.

Connaissances

Document control

eDMS/eQMS

ECOs/change orders

Lifecycle management

Process improvement

ISO 13485

CAPA/audit experience

Technical writing

Outils

eDMS/eQMS software

Description du poste

Job Description

We are looking for a Document Control Associate to support a company-wide effort to improve and rebuild its quality and document-control processes. This is a newly created position resulting from the division of an existing role.This person will manage controlled documentation within an electronic document or quality management system, run document change orders, and ensure SOPs, work instructions, specifications, forms, and product documentation follow established quality procedures.The ideal candidate will not simply process documents. They should be able to evaluate the current process, identify what needs to change, and take ownership of improving how documentation is created, reviewed, approved, revised, distributed, and archived.

Compensation: $31/hr - $39/hr. Exact compensation may vary based on several factors, including skills, experience, and education. Employees in this role will enjoy a comprehensive benefits package starting on day one of employment, including options for medical, dental, and vision insurance. Eligibility to enroll in the 401(k) retirement plan begins after 90 days of employment. Additionally, employees in this role will have access to paid sick leave and other paid time off benefits as required under the applicable law of the worksite location.

Skills and Requirements

2–4 years Document Control experience within medical device, biopharma, pharma, or regulated manufacturingExperience with eDMS/eQMS + ECOs/change orders, including revisions, approvals, releases, and document lifecycleIndependent/process-improvement mindset: can identify what isn't working and recommend how to make it betterMedical device experienceISO 13485CAPA/audit experienceTechnical writingExperience helping improve or rebuild an eDMS/eQMS process

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal employment opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment without regard to race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or the recruiting process, please send a request to [e-mail].