Quality Coordinator

JOB DESCRIPTION/DUTIES:
Under limited supervision, facilitate stability sample management and distribution.
Assist and support creation of Annual Product Review reports ensuring compliance with USDA, EU, FDA and company standards.
Perform pharmaceutical and biological stability support activities including, preparation and labeling of samples for storage, testing and disposal.
LIMS activities including scheduling, sampling, label generation and result entry/verification, as needed.
Maintain the stability samples in the various chambers, initiate new studies and place the samples into the appropriate storage condition.
Identify new pharmaceutical lots to be placed into the program to fulfil annual FDA requirements.
Assembly of data for Annual Product Review (APR) for pharmaceutical and biological products.
Activities will include preparation of binders, data queries in to change management, documentation, investigation, ERP and LIMS system(s).
Execution of reports and analysis of data including metric reporting.
Send out reminder emails for documents required monthly.
Review Bill of Specification, Monograph, and Outline of Production for current limits.
Assist with other group activities as requested, these activities are not limited to but may include use/support of quality systems (PDOCS, QTS, SQL*LIMS), risk assessments, change control, supplier management, and regulatory audits.
Perform other duties and special projects, as assigned.

SKILLS:

EDUCATION/EXPERIENCE MINIMUM REQUIREMENTS:
Associate's degree or equivalent post high school education or equivalent experience.
BS in a science discipline or equivalent experience preferred.
2 -4 years relevant work experience preferred.

TECHNICAL SKILLS REQUIREMENTS:
Proven ability to operate in an independent manner
Excellent interpersonal effectiveness and communication skills (written and oral)
Demonstrated ability to plan, organize and coordinate work, with a high attention to detail, through to completion.

PREFERRED TECHNICAL SKILLS REQUIREMENTS:
Knowledge of USDA, EU and FDA requirements of a biological and pharmaceutical manufacturing facility.
Working knowledge of computer systems: ARIBA (Spend Management), Documentum (PDOCS), TrackWise (QTS),SQL*LIMS
Working knowledge of Microsoft Office products (Word, Excel, Access, PowerPoint and SharePoint)FDA Regulations, MS Excel, MS Word, Pharmaceutical Manufacturing