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

Operation Second Chance Receives Grant from Petco Foundation

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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.

Free Flu Shots for Veterans

Free Flu Shots for Veterans
The cold and flu season is upon us and the Department of Veterans Affairs has once again teamed up with Walgreens Pharmacies nationwide to allow all veterans who are currently enrolled in the VA healthcare system to be able walk into any of the over 8000 Walgreens nationally (and the Duane Reade pharmacies in the New York metropolitan area) to receive a vaccination at no cost. 

Vaccinations will be available through 3/31/17.


Veterans wishing to receive the no cost vaccination simply need to present a Veterans Identification Card and a photo ID, at any participating Walgreens to receive the vaccination.  In addition, after the Walgreens pharmacist administers the vaccine, Walgreens will transmit that information securely to VA where it becomes part of the patient’s electronic medical record.


VA is committed to keeping Veteran patients healthy, and during this flu season, vaccination is the best way to prevent the spread of flu.  No matter where you live, visit your local VA clinic or Walgreens to get a free flu shot. 


• To find your local VA, visitva.gov/directory/guide/home.asp.

• To locate a Walgreens store near you, call 800-WALGREENs (800-925-4733), or gotocom/findastore.


•  To learn more about the partnership, call 1-877-771-8537 or visit ehealth.va.gov/Immunization.asp.


•  To get more information on flu and flu vaccine, visitpublichealth.va.gov/flu or www.cdc.gov/flu

Frederick County Veterans Treatment Court (VTC)

Frederick County Veterans Treatment Court (VTC)

 The Mission

To promote public safety and reduce criminal justice costs by assisting and supporting veterans through a coordinated response in collaboration with the veteran’s service delivery system, community based services, and the court system.

The Goals

1)         Honor veteran participants’ service to our country.

2)         Reduce veteran participants’ criminal recidivism and other court contacts.

3)         Facilitate veteran participants’ sobriety, abstinence and improved behavioral health by recognizing the precipitating factors that may have led them to the judicial system.

4)         Assure available VA benefits and services are accessed by veteran participants and integrate community-based treatment options and services for veteran participants as appropriate.

5)         Increase veteran participants’ compliance with treatment and other court ordered conditions by monitoring and encouraging positive progression through the VTC process in order to return productive, law-abiding citizens to the community.

 Overview

A VTC seeks to divert eligible Veteran-defendants with substance dependency and/or mental illness (PTSD) that are charged with felony or misdemeanor non-violent criminal offenses, to a specialized court docket.  The court substitutes a treatment problem solving model for traditional court processing.  Veterans are identified though evidence based screening and assessments.  The Veterans voluntarily participate in a judicially supervised treatment plan that a team of court staff, Veteran health care professionals, Veteran peer mentors and mental health care professionals develop with the Veteran.  At regular status hearings, treatment plans and other conditions are reviewed for appropriateness, incentives are offered to reward adherence to court conditions, and sanctions for non-adherence are handed down.  Completion of the program is defined according to specific criteria.  Many will have their charges dismissed upon successful completions and are assured of a non-incarcerative sentence upon completion.

This collaborative effort involves a number of organizations coming together with one goal – what is in the best interest of the Veteran.  The pilot program currently has the Veterans Administration Medical Center’s Justice Outreach Coordinator, Frederick County Health Department, Building Veterans, The Purple Moon Project, Veterans Support Network, MD’s DHMH, and judicial advocates including Judge Scott Rolle, the State’s Attorney’s office, probation officers, defense attorneys and others on board.  This list of supporting players will expand as needs are identified and sources for solutions brought into the mix.

 On Wednesday, October 26, 2016, Frederick County opened its first Veterans Treatment Court docket in Judge Scott Rolle’s Courtroom!  It was a wonderful experience to be part of this inaugural effort.  We are asking for your help.

 Project:  Flags, Challenge Coins and Incentives

 We are in need of the following items to support the VTC:

 Military Flags with poll and base: (Displayed only during VTC proceedings)

Army Flag                             $245.00

Marine Corps Flag              $245.00

Navy Flag                              $245.00

Air Force Flag                      $245.00

Coast Guard Flag                $245.00

 

Challenge Coins         $1,200 (for 200 coins) (2 coins per Veteran)

 Dog Tags (with inspirational words)   $320 (for 600 dog tags) (6 per Veteran)

To donate, please make checks payable to “Purple Moon Project / VTC Project.”  They will track the donations and pay invoices from a line item in their budget.  They are a non-profit, so any amount donated is tax deductible!  You will also get a letter of confirmation for your donation.

Craig Tyler, Executive Director

The Purple Moon Project, Inc. – 501(c)(3)  (non-profit) organization

PO Box 3093

Frederick, MD  21705

240-357-8081

Website: www.purplemoonproject.org

Email: craig@purplemoonproject.org

 

Thank you for partnering to make a difference in the lives of Veterans in need right here in Frederick County.

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.

 

Enterprise Car Sales is honoring Military Appreciation Month

During the month of November, Enterprise Car Sales is honoring Military Appreciation Month with a very special offer!

In honor of Veterans Day this November, all active United States military members, veterans and dependents, will have a FIRESTONE PREPAID MAINTENANCE PACKAGE VALUED AT $300 included in their used vehicle purchase from Enterprise Car Sales. Redeemable at any Firestone, Tires Plus, and affiliate locations.

This offer is valid nationwide at more than 120 Enterprise Car Sales dealerships. In the Washington, DC area, we have dealerships located in Rockville, Woodbridge, New Carrollton, and Marlow Heights. Search pricing, inventory, and locations at www.enterprisecarsales.com. See offer details below or at www.enterprisecarsales.com/thankyou.

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1: 1Offer applies to all active United States military members, veterans and dependents. Prepaid Maintenance Package will be in the form of a $300 Firestone Complete Auto CareTM gift card, which will be issued within 60 business days after purchase of vehicle. Offer valid only on Enterprise vehicles purchased 11/1/16 – 11/30/16. To receive the offer, active and veteran military personnel must present one of the following: Common Access Card, Uniformed Services ID Card, DD Form 214 / Report of Separation papers, or state-issued ID reflecting military status. Dependents of active military personnel must present a valid Uniformed Services ID Card. Offer void when 7-Day Repurchase Agreement is activated. No cash advances. Not valid on previous purchases. This offer cannot be combined with any other offer.

2: Gift card will be honored at all Firestone Complete Auto CareTM, Tires PlusTM and Hibdon Tires PlusTM locations. Not valid in CA and OR. Gift card expires 12/31/18. No card expiration in WA. Used vehicles were previously part of Enterprise short-term rental and/or lease fleet or purchased by Enterprise from other sources including auto auctions, with previous use possibly short term rental, lease or other.

Photo for illustration purposes only. The “e” logo, Enterprise and “Haggle-free buying. Worry-free ownership.” are trademarks of Enterprise Holdings, Inc. Firestone and Firestone Complete Auto Care are registered trademarks of Bridgestone Brands, LLC. Tires Plus and Hibdon Tires Plus are trademarks of Bridgestone Retail Operations, LLC. All other trademarks are the property of their respective owners. © 2016 Enterprise Car Sales. Visit enterprisecarsales.com for more details.

Stars, Stripes, and Snowflakes Holiday Party

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Blue Star Families invites you to attend
the Stars, Stripes, and Snowflakes Holiday Party!

Sunday, December 4, 2016
2:00 – 4:00 PM

Spates Community Club
Joint Base Myer-Henderson Hall
214 McNair Road, Bldg. 407
Fort Myer, VA


Stars, Stripes, and Snowflakes is a special time for us to recognize and celebrate our military families with a special visit with Santa, activities for the whole family, raffle prizes for the adults, and gifts for the children.

This event is for Wounded Warriors and service members
(E-6 and below) and their family members.

We look forward to celebrating the holiday season with you!

CLICK HERE TO REGISTER

This event is brought to you by Blue Star Families and is one of the numerous benefits you receive as a member. Please use the forward option below to share with anyone you know that would enjoy these benefits as well. 

8th Annual Tribute to America’s Veterans Concert

The Montgomery County Commission on Veterans Affairs is in collaboration with the Silver Spring Towne Center in sponsoring this event.  Once again this year, the Walter Reed Society is significantly supporting this event. We hope that there will be a great turnout.  Please see in email below more information about the event.  Morton Davis, Korean War Veteran will be keynote speaker.  There will be a tribute in memory of Fred Cherry, POW, Vietnam War.

Join us for the 8th Annual Tribute to America’s Veterans Concert Thursday, November 10th at 6pm in the Great Hall of the Silver Spring Civic Building. Along with saluting our Vets, this year’s event celebrates music and dance of the Korean War Era. You will not want to miss this evening of 50’s swing music and dance with the Natty Beaux!

The Natty Beaux (pronounced nat-tee bohs) are a swingin’ jump-blues/rockabilly band and 10-time winners of  Washington Area Music (WAMMIE) Awards. This fun-lovin’, finger-snappin’, hoppin’ and boppin’ combo featuring musicians from some of the Mid-Atlantic region’s finest groups including: Billy Coulter BandThe Junkyard SaintsAlexandria Kleztet and more. Folks just can’t sit still when they hear ’em play toe-tappin’ mid-century classics from Louis Prima, Ray Charles, Louis Jordan, Bobby Darin, Elvis, Frank Sinatra, Gene Vincent, Nat King Cole, Jerry Lee Lewis and other greats.
This event is not to be missed! Free and everyone welcome!
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