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QA Document Control Supervisor
MANCHESTER NH 03103
Category: Other
  • Your pay will be discussed at your interview

Job code: lhw-e0-90653225

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LSNE Contract Manufacturing

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  Job posted:   Thu Jun 7, 2018
  Distance to work:   ? miles
       
  1 Views, 0 Applications  
 
QA Document Control Supervisor
QA Document Control Supervisor




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JOB SUMMARY -


This position will be responsible for leading the QA Document Control team across multiple production facilities. This includes managing and executing the processes associated with the creation of new and revision of existing documents throughout the complete lifecycle in a regulated GMP environment. This position will be responsible to manage, coordinate, and maintain CGMP documentation, procedures, and records to ensure only controlled copies are reviewed, approved, issued, distributed, and archived.


JOB DUTIES -



+ Responsible for managing and directing staff to ensure proper and continuous document control support across multiple production facilities


+ Manage staff to project timelines effectively ensuring clear and concise communication to management


+ Continuously promote collaborative work environment across multiple production facilities


+ Writes and revises QA Standard Operating Procedures (SOP)


+ Writes / reviews / participates in Investigations related to Document Control activities


+ Responsible and accountable for implementation and administration of a eQMS software system as it relates to the corporate Quality Systems


+ Responsible to oversee the proper and timely issuance, maintenance and archiving of GMP controlled documentation / Batch Records / Testing Data Sheets / Equipment Log Books / Quality System event documents and Logs


+ Maintain Designated Satellite Areas for controlled documentation


+ Facilitate Client Batch Record Approvals


+ Track and Facilitate Periodic SOP reviews


+ Manage Record / Document Filing system


+ Assist in client audit preparation and reconciliation


+ Other duties as assigned


EDUCATION, PROFESSIONAL SKILLS, & EXPERIENCE -


+ Associates Degree with a minimum of 10 years' experience in a cGMP environment


+ Bachelor's Degree with a minimum of 7 years' experience in a cGMP environment


+ Experience in managing direct reports with proven leadership skills


+ Exceptional planning and organizational skills and the ability to multi-task and meet deadlines in a fast paced / team environment


+ Experience in maintaining accuracy and effectiveness of documentation processes in a fast paced GMPregulated environment


+ Experience with electronic document management systems is preferred


+ Detail oriented


+ Proficient in Microsoft Office (Word, Excel, and Access required; PowerPoint is a plus)


+ Strong internal customer service / people skills is required


+ Excellent professional verbal, written, and communication skills are required


+ Solid knowledge of FDA (21CFR 210, 211 & 820) and EU regulations are required



PHYSICAL REQUIREMENTS -



+ Requires the ability to communicate effectively using speech, vision, hearing and written word


+ Requires bending, squatting, climbing, reaching


+ Requires the ability to lift, carry, push or pull light weights (up to 20 pounds)




+ Must be able to travel between three production facilities



COMMUNICATIONS & CONTACTS -



+ Interacts with all cross-functional departmental staff.


+ Responsible for communicating the status of projects, the ability to escalate needed actions and communicate improvement opportunities to QA Management.


MANAGERIAL & SUPERVISORY RESPONSIBILITIES -


+ Responsible for directing activities of QA Document Control staff. Must be able to observe and identify potential issues and address satisfactorily.


+ Ability to provide hands-on leadership, coaching, and coordination of needed actions with a focus on achieving departmental and organizational goals.


+ This individual must be able to manage, plan, and multi-task with minimal guidance.



The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.


We are a fast growing, dynamic contract manufacturing privately held company specializing in process development, lyophilization and fill/finish located right in Southern NH.


We are always on the lookout for outstanding individuals, recent graduates, talented professionals, and experienced leaders with a strong work ethic, creative spirit and positive attitude.


We offer a competitive compensation and benefits package and a very generous paid time off benefit. Join our team!


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