Document Control Coordinator

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We're looking for passionate, talented individuals who share our commitment to improving lives. With a global workforce, we lead with pride and purpose-prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn't just our tagline, it's the higher standard we live by every day.

Job Description Summary

SUMMARY OF POSITION:

The Documents Control Coordinator serves as a documentation technical resource to the plant. She/he is the primary point of contact for the controlled document and related processes. Also serves as a back-up to Batch Record Review.

Job Description

ESSENTIAL FUNCTIONS :

• Oversees and administers the controlled document process for the site, ensuring compliance of the system with FDA regulations and company policies and procedures.

• Serves as the DMS administrator for the software system used to electronically house the Site's documents. Provides training to employees on how to use the system.

• Coordinates DMS related projects and improvements.

• Provides timely processing and administration of controlled documents.

• Provides word processing assistance to departments to ensure controlled documents and batch records are formatted consistently.

• Monitors completion status of periodic reviews and change control action items to ensure timely documentation of actions and maintain compliance.

• Periodically audits master copies of documents to ensure issued copies are current.

• Enters all revised documents into the Learning Management System in a timely manner so training can be conducted.

• Proofs APAP finished lot labels and batch records.

• Back-up for label administration including program label changes, adding new codes to labeling computer, and conducting label audit trails.

• Supports annual DMF updates.

Additional Functions:

• Provides support to investigations, both exceptions and OOS's to support product disposition.

• Provide support to intermediate labeling and tank inspections as needed.

DEPARTMENT SPECIFIC/NON-ESSENTIAL FUNCTIONS:

• Other duties as assigned, with or without accommodation.

• Provides administrative duties for the department, such as mail distribution, coordination of supplies, and maintenance for the fax and copy machines.

• Participates in a certified 5S Workplace System to ensure good housekeeping and organization.

MINIMUM REQUIREMENTS :

Education:

High school diploma, GED, or equivalent required.

Associate/Technical degree or higher preferred.

Experience:

Competency in MS Word, Excel, and Adobe is required.

1-3 years pharmaceutical manufacturing experience is preferred.

Experience using an electronic document system is preferred.

Preferred Skills/Qualifications:

Other Skills/Competencies:

Organization, follow-through, effective communication, and computer literacy.

Action Oriented, Conflict Management, Customer Focus, Functional / Technical Skills, Presentation Skills, Priority Setting, Written Communication

Demand for labels and record retrieval creates interruptions.

A high degree of concentration is required to prevent mix-up and consequent errors.

RELATIONSHIP WITH OTHERS/ SCOPE:

• This position will report to the Site Quality Director.

• This position consults with all levels of plant personnel on issues and projects as required. This position will also interact with personnel from other locations / positions within Mallinckrodt.

• No employees directly reporting to this position.

• This position requires self-motivation and daily execution of tasks with limited supervision interaction.

WORKING CONDITIONS:

• Generally normal office and meeting room conditions, but must complete some routine assignments in plant and non-air conditioned production environment.

• Exposure to fugitive emissions of chemicals typical for chemical operations.

• Position may require some travel.

• Must be able wear the required Personal Protective Equipment (PPE) as deemed necessary by EH&S, leadership team, corporate, or safety guidelines.

DISCLAIMER :

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of employees assigned to this position.

EEO Statement:

We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, or genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.?

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.