QA Document Control Specialist

SpectronRx • Indianapolis, IN

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About The Position

SpectronRx is a rapidly growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, IN, with additional locations in South Bend and Bunker Hill, IN, Danbury, CT and Europe. We are seeking an experienced QA Document Control Specialist to join our growing company. The QA Document Controller will Assist with the management and follow-up of the Quality Assurance System and/or Product to guarantee the compliance with SOPs, policies, and Quality agreements.

Requirements

• High School Diploma/GED required.
• Working knowledge of tools, methods, and concepts of quality assurance.
• Proficiency in Microsoft Office Applications.
• Solid knowledge of relevant regulatory standards.
• Good Communication Skills, both verbal and written.
• Strong attention to detail.
• Excellent organizational skills and attention to detail.
• Ability to read, analyze and interpret governmental regulations, general business periodicals, professional journals or technical procedures.
• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to solve problems and effectively communicate in-person and on the phone.
• Strong interpersonal communication skills for interacting with site personnel, inspectors, and internal and external vendors required.
• Thorough understanding of project management.
• Excellent organizational skills and attention to detail.
• Valid Indiana driver's license
• Pass a Background Check.

Nice To Haves

• Certificate in quality assurance is a plus.
• College Degree Preferred.
• Have Good knowledge of cGDP and cGMP
• Ability to train and be trained

Responsibilities

• Control of distribution of released documents.
• Manage the flow of documents, from issuance to filing/archival.
• Ensure documents are readily accessible and up-to-date
• Securely filing hard copy originals, superseded hard copy originals and supporting documents.
• Act as electronic database administrator and provide support as needed for the database.
• Control electronic database uploads of items as required.
• Ensure that all product review, CAPA, OOS, Deviation, and Change Control documentation is filed as applicable.
• Control the filing of all supporting documents (including but not limited to specifications, labels, MSDS, USP chapters, FDA references and FDA applications)
• Ensure that the corporate QA document file is updated.
• Minute all QA related meetings, coordinate attendee sign off as required and file.
• Coordinate the collection and distribution of consultant work orders and invoices.
• Assist purchasing to establish an approved supplier list.
• Assist as required with all QA activities.
• Performs other related duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED