Supervisor, QA Document Control in Burlington, MA at AMRI

Date Posted: 5/12/2020

Job Snapshot

Job Description

Description
AMRI provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. 

The QA Document Control Supervisor is a quality-focused individual who ensures processes conform to approved procedures and output documents are accurate. Responsible for maintaining the flow of controlled documents, department files and resource materials. Responsible for writing document control systems and putting them into action, logging, tracking and maintaining batch records, SOP’s, and all documentation associated with GMP activities, coordinating document control issues between internal departments and external clients and preparing reports regarding quality issues. 

Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. 
Responsibilities

•Compile, store, retrieve quality systems data and produce reports to monitor performance of operations functions
•Provide direction and guidance over staff 
•Evaluate staff’s career development plans through periodic reviews and provide mentoring to improve staff effectiveness and skills
•Monitor and conduct audits and quality checks 
•Make recommendations to improve Document Control procedures in reference to the management of documentation to establish and continue utilizing efficient methods with efforts of reducing costs
•Evaluate and mitigate potential records information management risks
•Provide individual, team and department error/accuracy information and identify areas for improvement
•Improve the visibility of documentation submitted and processed on time in accordance with project schedules
•Issue corrective actions where needed to drive compliance with organizational objectives
•Provide support to QA Operations as needed
•Administration of electronic documentation system
•Process Standard Operating Procedures, Batch Records, Validation Documents, Miscellaneous Reports and Material Specifications through the creation and revision process, obtaining approval signatures, Mastering and distribution both internally and with clients
•Verify the formatting, spelling, sentence structure, and coding of documentation prior to approval
•Implement, maintain and support documentation release and change activity
•Maintain a current index of standard operating procedures and material specifications
•Ensure changes  to documentation are adequately communicated to all affected parties
•Distribute and maintain reference binders for standard operating procedures and material specifications
•Archival of GMP documents
•Oversee the biennial review process for all documents
•Maintaining a chain-of-custody process for all documents that leave the archive room
•General support for all Document Control activities

Qualifications
•Minimum of an Associate’s Degree Required
•3 years of quality assurance experience in a regulated industry; pharmaceutical or medical device, with two years of direct document control experience
•Experience working with electronic document management systems (MasterControl a plus)
•Must be skilled in the use of computers and experienced in the use of Microsoft Office, Microsoft Access, Word, Excel and PowerPoint
•Ability to lift 50lbs

All interested applicants must apply online. AMRI is an Equal Opportunity Employer, we value diversity and inclusiveness. Minorities/females/veterans/individuals with disabilities/sexual orientation/gender identity are encouraged to apply.
Albany Molecular Research, Inc. is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000. Please note: The above-referred email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.

Job: Quality
Primary Location: US-MA-Burlington
Other Locations:
Organization: AMRI Burlington
Schedule: Full-time
Job Posting: May 12, 2020, 4:18:06 PM
Shift Type: Standard 8

AMRI is committed to providing equal opportunity to all job seekers including qualified individuals with disabilities. If you have any difficulty using our online application system due to a disability or believe you need a reasonable accommodation to search for a job opening or submit an application, you may use the alternative email address jobs@amriglobal.com to contact us about your interest in employment or you may call us at 518.512.2000.

Please note: The above referenced email address and telephone number are dedicated communication lines designed exclusively to assist job seekers whose disability prevents them from being able to apply online. Messages left for other purposes will not receive a response.