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This is

Hershita working as

Recruitment Specialist with

Experis part of Manpower Group.

Please have a look at the job description and if you are interested, please reply back with an updated copy of your Resume. Please send your updated resume to

() and I will be happy to have this moving swiftly.

Job Role: Quality System Specialist

Location: Harmans MD 21077

Duration: 6+ Months. (Possibility for extension)

Job Description:

1st shift 8-5pm schedule

This role is responsible for supporting the Quality Control team, including the implementation of the MODA (Mobile Data Acquisition) program, the implementation of this Environmental Monitoring paperless system includes, creation of sampling plans, metadata management and test methods verification and system qualification.

This position will be responsible for providing end-user support and account administration for all end-user groups, as well as responsible for system compliance. This position will be required to lead cross-functional teams comprised of laboratory, materials management, EH&S, and Quality personnel at the BWI facility and collaborate with other Client sites to align and improve the use of the MODA system.

Supports the Environmental Monitoring program:

Work with IT and Quality personnel to ensure system compliance.

Develop and execute validation scripts as needed for change control issues.

Identify operational improvement opportunities which MODA can provide solutions.

Lead cross-functional teams to develop site specific needs in a harmonized format.

Create and Review Sampling Plans for validation and routine monitoring using MODA.

Review Alert and Action levels for BWI Harmans suites based on first year data

Complete maps in MODA with sample locations for all EM sample types for additional clean room suites at BWI Harmans facility

Attend project meetings; fostering teamwork and project collaboration; communicating effectively with focus on problem-solving; other Quality- related tasks as needed.

Supports and ensures timely initiation, write up and closure of QC CAPAs, Investigations, Deviations and Change Controls.

Develop and/or revise site SOPs as well as developing specific MODA SOPs in collaboration with Vendor and the appropriate personal from the QC Microbiology team.

Participate in site quality and process improvement initiatives. Represent QC Microbiology on site project teams.

Other duties as assigned

Experience with ICH Guidelines / EU GMPs

Experience in using other electronic systems (LIMS, TrackWise, EDMS, Master Controls, etc.)

Experience with cGMP operations and other regulatory requirements relative to LIMS systems and validation procedures is required.

Familiar with quality risk management, regulations and their context.

Good working knowledge of quality systems and risk management.

Able to work in a team setting and independently under minimum supervision

Ability to work in fast paced environment

Creative individual with excellent trouble shooting skills

Requires the ability to produce results in with limited timelines, Experience with the development / review / approval of CAPAs / Deviations / Investigations within the pharmaceutical/ biologics industry

Ability to quickly learn and navigate electronic systems


Work independently under general supervision to meet department / company goals

Positive, professional attitude toward work and willingness to cooperate with co-workers and supervisors and to contribute to the team

Timeliness and accuracy in completion of tasks

Contributions to the team beyond general responsibilities

Identification of areas for improvement and leads implementation strategies for improvement

Exercises good judgment

Demonstrated understanding and adherence to Paragon policies and procedures

Ability to succeed in a team-oriented environment under dynamic conditions

Minimum of a B.S. in a Life Sciences discipline

+5 years' experience within the biologic, biopharmaceutical, or regulated pharmaceutical Quality Control Laboratory

1-2 years' experience in Quality Control / Compliance function

Experience with Environmental Monitoring Programs and microbial testing


Hershita Singhal

Talent Acquisition Specialist

Experis CORE+

Phone -Ext - 7147

100 Manpower Place

| Milwaukee, WI 53212

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