QMS Document Control Specialist

Promedmolding; Plymouth, Northern (MN, KY); Hybrid; USD 62,000 - 85,000; Full time

Benefits offered by this job

401k with company match

Profit Sharing Program

Medical Insurance

Health Savings Account/Flexible Spend

Vision Insurance

Life Insurance

Paid Family Medical Leave

Hospital Indemnity, Critical Illness,

Pet Insurance

Job summary

ProMed is seeking a Quality Documentation Control Specialist in Plymouth, MN, to manage the day-to-day operations of the document control system within a regulated pharmaceutical and medical device environment.

Responsibilities include maintaining master lists, archiving, and coordinating training related to controlled documents to ensure ALCOA data integrity and regulatory compliance.

Qualifications

• Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field.
• 0–2 years in a regulated industry (pharma, biotech, or medical device).
• GMP principles and FDA regulatory requirements (21 CFR Parts 210/211 and/or 820).
• Microsoft Office Suite proficiency (Word, Excel, Outlook).

Responsibilities

• Administer the document control system, including issuance, revision, approval routing, and archiving of controlled documents (SOPs, forms, specs).
• Maintain document master lists and revision histories for current versions.
• Manage document distribution and destruction of obsolete documents.
• Process document change requests and support change impact assessments with SMEs.

Skills

GMP knowledge

FDA regulatory understanding

Documentation management

ALCOA data integrity

Education

Bachelor’s degree in Life Sciences, Chemistry, Engineering, or related field

Tools

Microsoft Word

Microsoft Excel

Microsoft Outlook

MasterControl

Veeva Vault

Agile

Job description

ProMed is seeking a Quality Documentation Control Specialist in Plymouth, MN, to manage the day-to-day operations of the document control system within a regulated pharmaceutical and medical device environment.

Responsibilities include maintaining master lists, archiving, and coordinating training related to controlled documents to ensure ALCOA data integrity and regulatory compliance.