DOCUMENTATION CONTROL SPECIALIST
Smalley, Lake Zurich, IL, United States
Job Summary
The Documentation Specialist plays a vital role in supporting Smalley's Quality and Production departments by managing the creation, review, and archival of critical technical documents. This role ensures that all Standard Operating Procedures (SOPs), work instructions, and production records (such as batch records or inspection reports) are accurate, compliant with industry standards, and readily retrievable for audits.
Key Responsibilities
Document Control & Development: Draft, edit, and format technical documents, including SOPs and Work Instructions (WIs), by translating complex manufacturing processes into clear, user-friendly instructions.
Lifecycle Management: Coordinate the approval process for new or revised documents, ensuring proper version control and removal of obsolete versions from the production floor.
QMS Alignment: Maintain the Quality Management System (QMS) documentation to ensure alignment with ISO or other regulatory standards.
Record Audit: Review production batch records and quality inspection reports for accuracy, completeness, and adherence to Good Documentation Practices (GDP).
Compliance Checks: Ensure all required documentation is present and error-free before records are finalized or submitted for release.
Collaboration: Partner with production and quality teams to resolve gaps or discrepancies found during record reviews.
Records Management: Manage the physical and digital storage of controlled documents, ensuring they are organized for easy retrieval during internal or external audits.
System Maintenance: Input and update document metadata in the company's electronic document management system (EDMS) or ERP system.
Archival Compliance: Oversee the secure destruction of expired records and the long-term preservation of permanent quality records according to retention policies.
Qualifications
Education: Associate degree in a technical or business field; a Bachelor’s degree is a plus.
Experience: 2–5 years of administrative or documentation experience in a manufacturing, aerospace, or medical device environment.
Technical Skills:
Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Familiarity with ERP systems (e.g., SAP) or Document Management Software.
Knowledge of Good Manufacturing Practices (GMP) and ISO quality standards.
Soft Skills: Extreme attention to detail, strong organizational skills, and the ability to work independently in a fast-paced environment.
Physical & Environmental Requirements
Role is primarily office-based but requires occasional presence on the production floor.
Ability to lift up to 30 lbs (e.g., archival boxes).
Compensation & Benefits
A reasonable estimate of the hourly pay range for this role is $20.00 - $22.00 USD. Please note that actual salaries may vary within the range, or be above or below the range, based on factors including, but not limited to, education, training, experience, professional achievement, business need, and location. This role is bonus/and or incentive eligible.
EEO Statement
Smalley is an equal opportunity employer and believes in equal opportunity for all employees and applicants. Accordingly, all employment decisions are based on the principles of equal opportunity. These decisions include recruitment, selection, promotion, transfer, discipline, compensation, benefits, training, and other personnel actions involving persons in all job titles and shall occur without regard to race, color, religion, sex, pregnancy (including childbirth and related conditions), age, national origin, disability, genetic information, veteran or military status, sexual orientation, gender identity, creed, ancestry, marital status, or any other legally protected class as recognized by applicable law.
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The Documentation Specialist plays a vital role in supporting Smalley's Quality and Production departments by managing the creation, review, and archival of critical technical documents. This role ensures that all Standard Operating Procedures (SOPs), work instructions, and production records (such as batch records or inspection reports) are accurate, compliant with industry standards, and readily retrievable for audits.
Key Responsibilities
Document Control & Development: Draft, edit, and format technical documents, including SOPs and Work Instructions (WIs), by translating complex manufacturing processes into clear, user-friendly instructions.
Lifecycle Management: Coordinate the approval process for new or revised documents, ensuring proper version control and removal of obsolete versions from the production floor.
QMS Alignment: Maintain the Quality Management System (QMS) documentation to ensure alignment with ISO or other regulatory standards.
Record Audit: Review production batch records and quality inspection reports for accuracy, completeness, and adherence to Good Documentation Practices (GDP).
Compliance Checks: Ensure all required documentation is present and error-free before records are finalized or submitted for release.
Collaboration: Partner with production and quality teams to resolve gaps or discrepancies found during record reviews.
Records Management: Manage the physical and digital storage of controlled documents, ensuring they are organized for easy retrieval during internal or external audits.
System Maintenance: Input and update document metadata in the company's electronic document management system (EDMS) or ERP system.
Archival Compliance: Oversee the secure destruction of expired records and the long-term preservation of permanent quality records according to retention policies.
Qualifications
Education: Associate degree in a technical or business field; a Bachelor’s degree is a plus.
Experience: 2–5 years of administrative or documentation experience in a manufacturing, aerospace, or medical device environment.
Technical Skills:
Strong proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
Familiarity with ERP systems (e.g., SAP) or Document Management Software.
Knowledge of Good Manufacturing Practices (GMP) and ISO quality standards.
Soft Skills: Extreme attention to detail, strong organizational skills, and the ability to work independently in a fast-paced environment.
Physical & Environmental Requirements
Role is primarily office-based but requires occasional presence on the production floor.
Ability to lift up to 30 lbs (e.g., archival boxes).
Compensation & Benefits
A reasonable estimate of the hourly pay range for this role is $20.00 - $22.00 USD. Please note that actual salaries may vary within the range, or be above or below the range, based on factors including, but not limited to, education, training, experience, professional achievement, business need, and location. This role is bonus/and or incentive eligible.
EEO Statement
Smalley is an equal opportunity employer and believes in equal opportunity for all employees and applicants. Accordingly, all employment decisions are based on the principles of equal opportunity. These decisions include recruitment, selection, promotion, transfer, discipline, compensation, benefits, training, and other personnel actions involving persons in all job titles and shall occur without regard to race, color, religion, sex, pregnancy (including childbirth and related conditions), age, national origin, disability, genetic information, veteran or military status, sexual orientation, gender identity, creed, ancestry, marital status, or any other legally protected class as recognized by applicable law.
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