Job Information
Glenmark Pharmaceuticals Inc., USA Quality Assurance Specialist, Document Control in Monroe, North Carolina
Quality Assurance Specialist, Document Control
Department: QA Manufacturing
Location: Monroe, NC
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Glenmark Pharmaceuticals Inc., USA is a subsidiary of Glenmark Pharmaceuticals Ltd., a leading player in the discovery of new molecules - both New Chemical Entities (NCE's) and New Biological Entities (NBEs'), with eight molecules in various stages of clinical development. Glenmark Pharmaceuticals Inc., USA is a fast growing and robust US generics business, with plans to move into the innovative market as well. The USA subsidiary also markets APIs to regulated and semi-regulated countries.
POSITION SUMMARY :
Under the direction of the QA Document Control Supervisor, the QA Specialist - Document Control, will control the movement, filing, archiving, and securing of all documents with the objective of ensuring compliance to company policies and procedures. In addition, the QA Specialist will review, issue, and reconcile controlled documents according procedures.
JOB RESPONSIBILITIES :
Maintain quality system controls to ensure state of compliance
Take appropriate steps to reduce wastages and losses in the process and build improved efficiency
Under guidance of the Senior QA Specialist Document Control, the QA Specialist - Document Control will:
Respond to Document Control related activities throughout the site
Issue and reconcile controlled documents, process records for archival, retrieve documents as requested
Follow procedures as they relate to doc cell security and maintenance
Perform document review
Perform document implementation processes (Set Date)
Execute activities within the Document Management Systems in a compliant manner
Assist in the implementation of all new electronic systems for document management.
Other duties as required
Support all cross functional teams within the site for document control related needs
Support regulatory inspections and audits
Maintain documents per guidelines to ensure quick retrieval
Assist in implementing systems to enhance document management process and daily operation.
Education:
Minimum Associates degree in scientific discipline or closely related technical field of study
Experience :
0-2 years of Pharmaceutical and FDA/GMP industry experience is preferred.
Previous Quality experience is preferred.
Any quality certifications a plus
Knowledge and Skills :
- Must be proactive, results oriented, with a strong attention to detail.
- Self-starter with good work ethic and ability to work independently with minimum supervision and use good judgment, or as a contributing member of a team.
- Ability to manage multiple projects simultaneously, meet deadlines, and handle an ever changing, fast paced critical work environment.
- Excellent verbal and written communication. Must be able to read, write, and speak English.
- Good computer skills with basic knowledge of Microsoft programs, particularly Outlook, Word, Excel, etc.
Knowledge of /or SAP (Systems, Applications & Products in Data Processing), MasterControl, Trackwise, is a plus
Strong organizational, troubleshooting and problem-solving skills. Ability to analyze details and perform structured decision-making on a daily basis.
Strong interpersonal skills with ability to interact with all levels of personnel in a professional manner.
Good communications skills
GMP trainer a plus.
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