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Title : AXD- Compliance Specialist -704
State : Connecticut   Date : Jan 21, 2022
Experience Level :  
Position Type : Compliance Specialist      
Description
This position is for a leading pharmaceutical company. Below are the details of the engagement. If you are available and interested please send me your updated word resume & your expected hourly rate on W2 ASAP.
Looking forward to hearing from you soon.

Work Location: New Haven, CT

Job Title: Compliance Specialist

Duration: 12+ months (extendable) contract on W2



Summary:

Analytical Sciences Compliance Specialist (or Process Development Associate) is responsible for maintaining quality compliance in Analytical Sciences laboratories by identifying quality requirements; disseminating policies, procedures, conducting audits, recommending improvement plans and performing compliance tasks. Additionally, this candidate will be responsible for all equipment maintenance including maintaining calibration schedules and approving equipment qualification packages.

Responsibilities:

a. Responsible for generating, reviewing, providing assessments and maintaining out of specification (OOS) reports, deviation reports, CAPAs and Change Control for Analytical Sciences.
b. Provide key assistance in QA audits and design correction action to observations
c. Maintain the training matrix of GAPD
d. Conducts reviews of new procedures and proposed changes to current procedures for compliance with regulatory and corporate requirements; presents findings
e. Identifies opportunities for improvement in systems and makes recommendations for effective changes  to ensure compliance with cGMP
f. Oversee equipment maintenance including maintaining PM calendar, schedule calibration and services, review, approve and maintain equipment binders and log books
g. Maintain Inventory of reference standards, critical samples and reagents. Coordinate qualification of reference standards and prepare qualification reports.
h. Create timelines and plans to meet established targets; goals and objectives

Competencies:

The candidate must demonstrate the following competencies:
a. Collaboration: Carries out cross functional team meetings, taking meeting minutes, communicates effectively and professionally via email and in person, understands customer service etiquette
b. Technical Expertise: Knowledge in GMP or GDP, compliance, regulatory guidance
c. Decision Quality: Understands "big pictures" for projects and tasks involved and prioritize work accordingly. Communicates and coordinates cross-functionally
d. Accountability: Effectively drives quality improvement projects to completion, coordinates tasks and action items required for project completion

Education:
 A successful candidate will typically hold a bachelor’s degree in the science field.

Qualifications:

The Compliance Specialist, Analytical Sciences should have:
a. Experience with quality improvement projects
b. Experience with TrackWise or equivalent quality system for change control, deviation, CAPA, Lab Investigation
c. Experience with Veeva Vault EDMS or equivalent
d. Experience with procedure creations or revisions
e. Experience with maintenance of training curriculum and/or training files.



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Many Thanks,   

Sree Kanth
Recruitment Manager
Sree@newageclinical.com

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