Document Control Specialist Job in Rochester, NY :

Job Description

Job Description

Document Control SpecialistJob in Rochester, NY :

Contract Pay Rate Range : $30.00- 38.00 per hour based on experience, education, geographic location and other factors.

Please no 3rd party or c2c candidates

We are seeking a detail-oriented and highly organizedDocument Control Specialistto manage and maintain controlled documentation in compliance withFDA regulations,ISO standards, and internal quality systems. This role is critical to ensuring the integrity, accessibility, and regulatory compliance of all documentation supporting our operations.

Key Responsibilities of the Document Control SpecialistJob in Rochester, NY :

Administer and maintain the Document Control System (electronic and paper-based).

Manage document lifecycle including creation, review, approval, distribution, revision, and archival.

Ensure compliance with 21 CFR Part 11 , 21 CFR 820 , and ISO 13485 requirements.

Process Document Change Orders (DCOs), Deviations, and CAPAs.

Support internal and external audits by providing accurate and timely documentation.

Collaborate with cross-functional teams (QA, RA, RD, Manufacturing) to ensure documentation supports regulatory and operational needs.

Train employees on document control procedures and systems.

Monitor and report on document control metrics and compliance status.

Maintain Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR).

Qualifications of the Document Control SpecialistJob in Rochester, NY :

Associate’s or Bachelor’s degree in a related field (Life Sciences, Quality, Regulatory Affairs preferred).

2+ years of experience in document control within an FDA-regulated environment.

Proficiency with electronic document management systems (e.g., MasterControl, Agile, Veeva).

Strong understanding of FDA regulations, ISO standards, and cGMP practices.

Excellent organizational skills and attention to detail.

Strong communication and interpersonal skills.

Ability to work independently and manage multiple priorities.

Preferred Skills

Experience supporting FDA inspections or ISO audits.

Familiarity with validation documentation and quality system records.

Knowledge of risk management and change control processes.

For more information or to be considered for the Document Control SpecialistJob in Rochester, NY please contact Thomas McCarthy at mailto : Thomas.McCarthy@akkodis.com ">

Thomas.McCarthy@ akkodis.com

Pay Details : $30.00 to $38.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer / Veterans / Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https : / / www-uat.modis.com / en-us / candidate-privacy

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and / or security clearance requirements, including, as applicable :

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only : 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.

Company Description

Global Footprint, Local Impact : As part of the world's second-largest ER&D company, you'll join a network of 50,000 professionals across 30 countries, each contributing to impactful projects worldwide while benefiting from a close-knit community at a local level.

Diverse Career Paths : With services ranging from specialist recruitment to cloud infrastructure and sustainability, Akkodis offers a multitude of career paths. Whether you're a software developer, data analyst, or sustainability expert, there's a place for your skill set.

Commitment to Innovation : Innovation is our cornerstone. With continuous investments in analytics and market intelligence, we not only predict the future of technology – we create it. Your ideas and innovations will have the space to flourish.

Continuous Learning and Development : The Akkodis Academy offers unrivaled opportunities for learning and professional growth, ensuring you remain at the forefront of your field. Our culture values continuous improvement, both for our company and for your career.

Inclusive and Collaborative Culture : We believe in the power of diverse perspectives and collaborative work environments. At Akkodis, you'll find a community where inclusivity drives innovation and where every voice is heard.

Our Evolution and Your Role in It

Akkodis emerged from the strategic merger of AKKA Technologies and Modis in 2023, under the Adecco Group. This fusion created a powerhouse in digital engineering and technology, blending European engineering finesse with global technological capabilities. As we write our next chapter, your skills and vision will be instrumental in driving our continued success.

Empowering the Future

We're not just creating solutions; we're empowering industries to be more efficient, sustainable, and forward-thinking. Our work in industrial automation, product development, and custom software solutions is setting new standards in technology and engineering.

Join the Akkodis Community

At Akkodis, you're more than just an employee – you're a vital part of a community shaping the future. We're excited to see where your expertise can take us. Discover where you fit in our diverse range of opportunities and start engineering a smarter future with us today.

Company Description

Global Footprint, Local Impact : As part of the world's second-largest ER&D company, you'll join a network of 50,000 professionals across 30 countries, each contributing to impactful projects worldwide while benefiting from a close-knit community at a local level.\r\n\r\nDiverse Career Paths : With services ranging from specialist recruitment to cloud infrastructure and sustainability, Akkodis offers a multitude of career paths. Whether you're a software developer, data analyst, or sustainability expert, there's a place for your skill set.\r\n\r\nCommitment to Innovation : Innovation is our cornerstone. With continuous investments in analytics and market intelligence, we not only predict the future of technology – we create it. Your ideas and innovations will have the space to flourish.\r\n\r\nContinuous Learning and Development : The Akkodis Academy offers unrivaled opportunities for learning and professional growth, ensuring you remain at the forefront of your field. Our culture values continuous improvement, both for our company and for your career.\r\n\r\nInclusive and Collaborative Culture : We believe in the power of diverse perspectives and collaborative work environments. At Akkodis, you'll find a community where inclusivity drives innovation and where every voice is heard.\r\n\r\nOur Evolution and Your Role in It\r\n\r\nAkkodis emerged from the strategic merger of AKKA Technologies and Modis in 2023, under the Adecco Group. This fusion created a powerhouse in digital engineering and technology, blending European engineering finesse with global technological capabilities. As we write our next chapter, your skills and vision will be instrumental in driving our continued success.\r\n\r\nEmpowering the Future\r\n\r\nWe're not just creating solutions; we're empowering industries to be more efficient, sustainable, and forward-thinking. Our work in industrial automation, product development, and custom software solutions is setting new standards in technology and engineering.\r\n\r\nJoin the Akkodis Community\r\n\r\nAt Akkodis, you're more than just an employee – you're a vital part of a community shaping the future. We're excited to see where your expertise can take us. Discover where you fit in our diverse range of opportunities and start engineering a smarter future with us today.