QA Document Control Specialist

Quality Assurance Document Control Specialist

COMPANY OVERVIEW

SpectronRx is a growing Contract Development and Manufacturing Organization (CDMO) based in Indianapolis, Indiana, and production locations in South Bend, IN; Bunker Hill, IN; and Danbury, CT with plans for additional future production facilities. 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.

ESSENTIAL FUNCTIONS

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 Ensure documents are readily accessible and up-to-date Securely filing hard copy originals, superseded hard copy originals and supporting documents.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. Physical Ability

• Must be able to lift up to 50 pounds at a time and stand for prolonged periods. Attention to Detail
• Ability to accurately count, verify, and record data. Active Listening
• Giving full attention to instructions and communications, asking questions as appropriate. Speaking
• Talking to others to convey information effectively. Time Management
• Managing own time to prioritize tasks and meet deadlines. Coordination
• Adjusting actions in relation to others' actions in a team environment. Oral Comprehension
• The ability to listen to and understand information and ideas presented through spoken words and sentences. Written Comprehension
• The ability to read and understand information and ideas presented in writing. Basic Math Skills
• Ability to count accurately and perform basic arithmetic for reconciliation. Organizational Skills
• Ability to maintain orderly areas and accurate records.

TRAVEL Regular travel is minimal.

REQUIRED EDUCATION AND EXPERIENCE

High school diploma or equivalent education required. Proficiency in Microsoft office (Microsoft Word, Excel, and Outlook, Microsoft PowerPoint) and Adobe Acrobat required. Excellent customer service Excellent communication and organizational skills. Ability to train and be trained. Strong attention to detail. Excellent organizational skills and attention to detail.

PREFERRED EDUCATION AND EXPERIENCE

Familiarity with a manufacturing or production environment. College Degree Preferred. Certificate in quality assurance is a plus. Have Good knowledge of cGDP and c

GMP ADDITIONAL REQUIREMENTS

Valid Indiana driver's license. Pass a Background Check. Prolonged periods of standing, walking, bending, and lifting.

ADDITIONAL INFORMATION/BENEFITS

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. We recognize that people come with a wealth of experience and talent beyond just the technical requirements of the job. If your experience is close to what you see listed here, please still consider applying. Diversity of experience and skills combined with passion is a key to innovation and excellence; therefore, we encourage people from all backgrounds to apply to our positions. Please let us know if you require accommodation during the interview process. We are an equal opportunity employer. Qualified applicants shall be considered for all positions without regard to race, color, sex, religion, national origin, age, disability, veteran status, or any other status protected by federal, state or local law. Refusal to submit to testing will result in disqualification of further employment consideration.