Sr. Document Control Coordinator (Indianapolis, Indiana, US, 46268) chez None
None · Indianapolis, États-Unis d'Amérique · Onsite
- Professional
- Bureau à Indianapolis
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This role does not offer sponsorship for work authorization. External applicants must be eligible to work in the US.
Your Role:
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.
Major Position Activities & 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
- Performs special projects and other duties as assigned.
- Providing documentation support during regulatory inspections/external audits of the facility.
- Serves as a delegate for Manager, Training and Document Control when needed.
- This position is non-supervisory, and performance is tracked through various departmental and company metrics. The incumbent is expected to trouble shoot Doc Center problems.
Who You Are
Minimum Qualifications:
- 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
Preferred Qualifications:
- 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 verbalDetail-oriented, flexible, able to interact well with varied organizational levels, and excellent teamwork skills.
- Some lifting of file boxes required up to 30 lbs.
Pay Range for this position: $95,100-$142,700
The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job-related factors. Position may be eligible for sales or performance-based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. For more information click here
What we offer: We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We believe that this variety drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress!
Apply now and become a part of a team that is dedicated to Sparking Discovery and Elevating Humanity!
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