MacroGenetics – Job Posting

Position Description

Manager or Associate Manager, QA Document Control

To apply, please go to https://careers-macrogenics.icims.com/jobs/1034/manager-or-associate-manager%2c-qa-document-control/job

 Summary of Position

This position is responsible for managing the document control program at MacroGenics Inc. Individual will supervise the document control group and interface with management at all levels to ensure overall compliance with the document control program.  Will implement the document control procedures and administer the training program requirements, drive resolution to related issues and concerns, and provide status reports to Sr. Management on a routine basis.  This position will also supervise, coach and mentor direct reports.

Responsibilities and Job Duties:

  • Coordinate the document control training program utilizing Master Control including conducting training sessions, monitoring the adherence to training requirements and identifying any individuals, deficiencies or areas of non-compliance. Organize and chair the quarterly training status meetings to report on training program status for employees and raise concerns or issues with group to identify possible remedies, next steps and any further actions
  • Prepare and provide monthly quality metrics and other reports to supervisor to discuss at quarterly Quality Council Meetings.  May need to investigate and/or resolve identified concerns or issues in partnership with other functional managers.  Will then report out findings and recommendations and/or actions taken.
  • Conducts audits of off-site document storage facilities to determine if all industry standards and regulations for document storage in a GXP environment are being followed and applied. Prepares audit report and distributes to supervisor and senior management, and if issues or concerns are identified must work with vendor to implement corrective action, or modify vendor’s qualification status per internal procedures.
  • Ensures that all quality documents are archived properly and in accordance with all regulatory requirements by his team and other employees for our off-site storage facilities. Communicates archiving procedures and may assist with archiving process
  • Oversees the GXP document control room and ensures that all documents are being stored properly and in accordance with required regulations and that all approved users have appropriate access and understand the document storage rules and regulations. Addresses any routine issues or problems and raises more complex situations to supervisor for guidance.   Develops ideas and recommendations for improving existing systems and plans for changes to document control processes and/or procedures as necessary to align with future commercial expectations
  • Maintain current Standard Operating Procedures (SOP) binders ensuring that the contents are accurate for the area and the binder is complete. Must replace missing documents and identify and resolve any other binder deficiencies
  • Maintain current quality documents and templates on company intranet or in the electronic document management system so that employees have access to the timeliest and accurate information
  • Issues manufacturing batch records for batch production and protocols to Quality Control (QC), Validation or IT per SOPs. Issues books containing QC controlled forms and ensures that all forms are accounted for and that data integrity has not been compromised
  • Oversees scanning and filing of master and executed documents and that they are filed or stored appropriately and in accordance with relevant regulations
  • Perform supervisory duties such as hiring, coaching, training and mentoring direct reports.
  • Assists with special QA projects and other duties as assigned

Qualifications

 Experience – Manager level

  • Minimum of 8 years of experience in document control
  • At least 4 years of experience in a life science GMP regulated manufacturing facility

Experience – Associate Manager level

  • A minimum of 6 years of experience in Quality area with an emphasis on document control
  • At least 3 years of experience in a life science GMP regulated manufacturing facility

Education – both levels

BS degree in a related field or equivalent years of experience

 

Experience – both levels

  • Experience with paper-based and electronic document management systems
  • Ability to communicate effectively with subordinates and with peers and other management levels
  • Capable of influencing through education and building understanding
  • Prior experience in a commercial environment
  • Previous experience as a supervisor with direct reports

Knowledge, Skills and Abilities

  • Demonstrated ability to engage employees
  • Must have excellent interpersonal and people management skills
  • Must be able to manage multiple projects at once
  • Proficient using MicroSoft Office, specifically with Word, Excel and PowerPoint

 

Preferred Qualifications

  • Document Control or Records Management specific training or certifications
  • Prior experience with Master Control
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Operation Second Chance Receives Grant from Petco Foundation

petco-foundation

MEDIA ALERT

Contact: Vanessa Toner, 301-972-1080, vanessa@operationsecondchance.org

Petco Foundation Invests in Operation Second Chance’s Life-Changing Work Supporting Service, Therapy and/or Working Animals

Grant of $3,000.00 will extend efforts to help pets and people live their best lives

WHO: The Petco Foundation recognizes Operation Second Chance’s success in its mission to help people live their best lives with service, therapy and/or working animals.

WHAT: Operation Second Chance received a grant award of $3,000.00, which will extend its ability to provide financial assistance to those veterans needing help with the costs of having a certified service dog.

For more information about Operation Second Chance or the Petco Foundation, visit http://www.operationsecondchance.org/ or http://www.petcofoundation.org. Join the conversation on Facebook, Twitter and Instagram or by using the hashtag #PetcoFoundation.

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