Document Control Specialist

Company Description

Nemera is a world leader in the design, development, and manufacturing of drug delivery devices for the pharmaceutical, biotechnology, & generics industries. With locations worldwide, some of our services and products include eyedroppers, pumps, valves, inhalation devices, airless dispensers, and auto-injectors.

Job Description

Position Purpose: The function of the Document Control Specialist is to update, document, and maintain all quality programs in accordance with departmental procedures.

KEY RESPONSIBILITIES/ESSENTIAL FUNCTIONS:

• Process document change requests in the document control system in accordance with procedure
• Ensure documentation processing is performed properly and within time requirements
• Maintain Certificate of Compliance and Lot Information sheets
• Maintaininternal documentation logs
• Process changes to quality and safety documentation and update as required
• Support Records Retention
• Process, print, distribute, and reconcile Visual Defect References
• Maintain a two-year review of controlled procedures
• Assists Compliance Manager during customer audits
• Perform special projects as directed by Compliance Manager or Plant Quality Manager
• Performs Periodic Review
• Identify system(s) inefficiencies that contribute to increased quality costs.
• Supports and maintains all policies of the company including but not limited to applicable FDA regulatory and ISO requirements, Health and Safety Requirements and Continuous Improvement initiatives.
• Other duties as assigned

POSITION REQUIREMENTS:

• High school Diploma or equivalent
• One year experience in an FDA regulated environment preferred
• Demonstrated organizational skills and Intermediate to Advanced level knowledge of PC applications such as Microsoft Word, Excel and SAP Database software required.
• Able to lift up to 30 lbs.
• Able to push and pull items.
• Ability to sit, stand and walk 80% of shift.

PREFERRED KNOWLEDGE/SKILLS:

• Excellent communication skills with the ability to understand, read, write, and speak English
• Ability to work without direct supervision, stay on task, prioritize department and production needs, and meet daily deadlines

WORK ENVIRONMENT:

• Office and clean room environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel
• Ability to travel between office and production departments as well as company buildings required

ADDITIONAL NOTES

• This Job Description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee and may be revised at any time by the Company.

Qualifications

POSITION REQUIREMENTS:

• High school Diploma or equivalent
• One year experience in an FDA regulated environment preferred
• Demonstrated organizational skills and Intermediate to Advanced level knowledge of PC applications such as Microsoft Word, Excel and SAP Database software required.
• Able to lift up to 30 lbs.
• Able to push and pull items.
• Ability to sit, stand and walk 80% of shift.

PREFERRED KNOWLEDGE/SKILLS:

• Excellent communication skills with the ability to understand, read, write, and speak English
• Ability to work without direct supervision, stay on task, prioritize department and production needs, and meet daily deadlines

WORK ENVIRONMENT:

• Office and clean room environment that may include moderate noise levels and required appropriate PPE and cleanroom apparel
• Ability to travel between office and production departments as well as company buildings required

Additional Information

Why Join Nemera?

At Nemera, we prioritize patients when creating drug delivery devices, understanding that accurate dosing and ergonomics are crucial for treatment adherence. Joining Nemera means becoming part of a team that enjoys working together and consistently delivers on its commitments. We take pride in our work because it improves patients’ lives.

We look forward to receiving your application (resume submitted in English is appreciated). We offer varied jobs job in an international group, if you want to discover more about Nemera, please look at our website www.nemera.net

Know someone at Nemera? We have a Referral Program so, be sure to have them submit you as a referral prior to applying for this position!

Nemera is an equal opportunity employer and does not discriminate against any person on the basis of race, religion, color, gender, gender identity, sexual orientation, age, national origin, disability, veteran status, or any other protected class indication. This company is required by federal law to hire only persons who can establish they are eligible to work in the United States.
The Nemera timekeeping system utilizes finger scan. Our biometric policy is available upon request at [email protected]