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

Veterans Hiring Preferences

Senate Bill 245, Veterans Hiring Preferences – Spouses, became law on October 1st.  Senate Bill 245  authorizes an employer to grant a hiring and promotion preference to an eligible veteran, the spouse of an eligible veteran who has service-connected disability, or the surviving spouse of a deceased eligible veteran.

All states grant some form of employment preference to veterans in the public sector, but private employers have been hesitant to favor veterans because of provisions in federal law that prohibit discrimination in hiring. An exception to the federal law, however, allows preferences for veterans if they are authorized under federal, state, or local law. An eligible veteran is a veteran of any branch of the U.S. Armed Forces, including the National Guard and the military reserves, who has received an honorable discharge or a certificate of satisfactory completion of military service.

A copy of the legislation may be found by clicking here.

 

Free Rides to Veterans for Job Interviews

Uber and Lyft to offer free rides to veterans for job interviews

By Leo Shane III and Andrew Tilghman, Staff writers 8:10 a.m. EST November 10, 2015

An Uber app is displayed as cars drive by in Washington, D.C. The ride-sharing services Lyft and Uber will be donating free rides to veterans who need transportation for job interviews.(Photo: Andrew Caballero-Reynolds/AFP/Getty Images)

Ride-sharing services Uber and Lyft will donate tens of thousands of free trips to veterans for transportation to work, job interviews and other critical needs, officials announced Tuesday.

The move is part of a broader effort by the White House’s Joining Forces initiative to help end homelessness among veterans, and encourage corporate partners to fill the unmet needs of America’s military families. Initiative officials made the announcement on behalf of the two companies on the eve of Veterans Day.

The ride-sharing services offer on-demand transportation services in metropolitan areas across the country, allowing people to use their phones to request and pay for cab service.

“We have heard time and time again that transportation to and from work and job interviews is often a significant hurdle for homeless veterans trying to find work,” Air Force Col. Nicole Malachowski, Joining Forces executive director, wrote in a statement hailing the announcement.

“If a veteran is working a night shift or employed in a remote area of a city, public transportation is not always a viable option, and there is limited funding available for alternative transportation.”

Company officials said the rides will be made available in coming months, through veterans organizations working with the Labor Department’s Homeless Veterans’ Reintegration Program.

In addition, Uber officials announced plans to allow customers to donate $5 toward additional rides for veterans on Veterans Day, through the company’s apps.

The most recent estimates put the number of homeless veterans in America at just under 50,000 people. The National Coalition for Homeless Veterans estimates that more than two-thirds of those veterans live without access to reliable transportation, limiting their ability to gain and hold jobs.

More information on the free rides will be available on the Department of Labor website, and on the Uber and Lyft websites.

Job fairs for service members, vets being held nationwide this fall

The full list online- Check it out here!

We thought we would highlight a few local to the DMV:

Baltimore

Quantico, Va.

Fredericksburg, Va.

  • JobZone Job Fair, 3-7 p.m. Dec. 3, Fredericksburg Expo Center and Conference Center, jobzoneonline.com

Springfield, Va.

McLean, Va.

Vienna, Va.

Lexington Park, Md.

  • JobZone Job Fair, 3-7 p.m. Nov. 10, Bay District Volunteer Fire Department social hall, jobzoneonline.com

Linthicum Heights, Md.

Washington, D.C.

New Federal Jobs

Additional jobs posted today. Click the link to learn more and apply!!

Job Title Job Location Public Department Deadline
Lead Medical Support Assistant BIRMINGHAM, AL Gov Veterans Affairs 09/18/2015
Supervisory General Engineer TUSKEGEE, AL Gov Veterans Affairs 09/21/2015
Administrative Assistant Oa MOBILE, AL Gov Labor 09/25/2015
Financial Management Analyst HUNTSVILLE, AL Gov Army 09/24/2015
Child and Youth Program Assistant Cy Cdc FORT RUCKER, AL Pub Army 09/17/2015
Supervisory Contract Specialist FORT RUCKER, AL Gov Army 09/24/2015
Information Technology Specialist Policy and Planning MOBILE, AL Gov Army 09/21/2015
Army Substance Abuse Program Prevention Coordinator ANNISTON, AL Gov Army 09/25/2015
Senior Program Analyst Bm Bsp BIRMINGHAM, AL Pub Treasury 09/17/2015
Resource Scheduling Program Manager FORT RUCKER, AL Gov Army 09/17/2015
Electrician BIRMINGHAM, AL Gov Veterans Affairs 09/17/2015
Firearms and Toolmark Examiner HUNTSVILLE, AL Pub Justice 09/21/2015
Firefighter TUSKEGEE, AL Gov Veterans Affairs 09/30/2015
Materials Examiner and Identifier Forklift Operator ANNISTON, AL Gov Defense 09/21/2015
Supervisory Hr Specialist Training HUNTSVILLE, AL Gov Defense 09/17/2015
Equipment Specialist MONTGOMERY, AL Gov Army 10/10/2015
Aircraft Operations Officer MONTGOMERY, AL Gov Air Force 09/16/2015
Senior Operations Research Analyst Research and Analysis BIRMINGHAM, AL Gov Treasury 09/23/2015

New Job Search Results from federalgovernmentjobs.us

Operation Second Chance gets sent these job posts each week. If you are interested in applying please click the link for details on how to apply.

Job Title Job Location Public Department Deadline
Supervisory Program Manager HUNTSVILLE, AL Gov Army 09/17/2015
Supervisory Sports Specialist HUNTSVILLE, AL Pub Army 09/11/2015
Assistant Experimental Facility Development Pressurants and Propellants HUNTSVILLE, AL Pub NASA 09/21/2015
Library Technician Nf FORT RUCKER, AL Pub Army 09/15/2015
Supervisory Public Affairs Specialist HUNTSVILLE, AL Pub Defense 09/14/2015
Electronics Engineer HUNTSVILLE, AL Pub Defense 09/16/2015
Key Program Technician MONTGOMERY, AL Gov Agriculture 09/21/2015
Electronics Engineer HUNTSVILLE, AL Pub Defense 09/16/2015
Administrative Services Assistant Office Automation MONTGOMERY, AL Gov Justice 09/21/2015
Administrative Services Assistant Office Automation MONTGOMERY, AL Pub Justice 09/14/2015
Intelligence Operations Specialist HUNTSVILLE, AL Pub Defense 09/14/2015
Program Analyst HUNTSVILLE, AL Gov NASA 09/10/2015
Public Affairs Specialist HUNTSVILLE, AL Gov Defense 09/14/2015
Acquisition Analyst HUNTSVILLE, AL Pub Army 09/14/2015
It Specialist Security HUNTSVILLE, AL Gov Defense 09/14/2015
Safety and Occupational Health Manager MONTGOMERY, AL Gov Air Force 09/14/2015