Sr. Document Control Coordinator

Merck KGaA Darmstadt Germany • Indianapolis, IN

99d • $95,100 - $142,700

About The Position

This Document Control position is concerned with the generation and maintenance of Document Control records and departmental SOPs and batch records. The incumbent will be responsible for the day to day tasks in this key quality system through adherence to company and departmental procedures.

Requirements

• Bachelor's degree or equivalent experience in document control or related field.
• Minimum 3 years experience with electronic document management system(s).
• Desktop publishing including proficiency in WORD, Excel, Access, Photo Editor, and Adobe Acrobat.

Nice To Haves

• Ability to successfully follow up on projects to achieve resolution and completion.
• 1 year or more Pharmaceutical experience with cGMPs preferred.
• Excellent communication skills, both written and verbal.
• Detail-oriented, flexible, able to interact well with varied organizational levels, and excellent teamwork skills.
• Some lifting of file boxes required up to 30 lbs.

Responsibilities

• System Administrator of the electronic documentation system: supporting users by answering questions, one-on-one training, trouble shooting, working with IT on specific cases, and providing support for any changes made to the system via Modification Change.
• Controls Administrator for Training System: updating/creating training materials (JQRs and TACs), creating curriculums/training for procedures/updates/processes, and assigning training to the required individuals.
• Technical judgment in decision making and technical training of departmental peers.
• Initiating/owning/investigating exceptions and issues related to Document Control in the Quality Tracking System.
• Processing change orders, drafting documents, editing and processing of documents in the electronic document system.
• Answering questions, customer assistance with drafting/ requests from individual users.
• Issuance and logging of batch records, check sheets and associated forms.
• Maintaining electronic document repositories and document share file directories.
• Logging in/auditing/searching/filing of documents.
• Issuance, tracking and archiving of all LUMAC, QC Data, and other GMP logbooks.
• Preparation of departmental metrics.
• Document Control representative on interdepartmental teams and projects.
• Expediting requests to the Doc Center.
• Updating/creating Document Control SOP.
• Processing/expediting document requests from Regulatory, and placing them into the designated site for each submission.
• Providing documentation support during regulatory inspections/external audits of the facility.
• Serves as a delegate for Manager, Training and Document Control when needed.
• Performing special projects and other duties as assigned.

Benefits

• Health insurance
• Paid time off (PTO)
• Retirement contributions
• Other perquisites

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree