Overview
OTC Program Coordinator Jobs in Totowa, New Jersey, USA at Englewood Lab, Inc
Position: Global OTC Program Coordinator
Title: Global OTC Program Coordinator
Reports to: Head of Quality
Department:Quality Assurance/ Quality Control/ Regulatory
Responsibilities:
Facilitate communication between the three OTC Factories (Sites) to support smooth, quick sharing of OTC Quality and Regulatory information, data, results and reports.
Facilitate the timely and accurate response to each Factory’s requests with regards to Quality / GMP documents, samples management, and communications as it relates to quality responsibilities, including the release of RMs, intermediates, bulk & FGs; and regulatory communications.
Ensure accuracy and completeness of all quality documents forwarded to each Factory.
Review and facilitate the forwarding of samples to testing sites, communication of test reports, mediation to resolve missing documents or test requirements, and follow-up to complete resolutions of open OTC issues between the Sites.
Participate in site calls, meetings, conference calls as the Quality liaison to support new launches, scale-ups, process/system validations, investigations, audits and inspections.
Assist, as needed, R&D, Customer Service (CSRs), Process Engineering, etc., to expedite cross-Factory OTC requests.
Maintain tracker of open quality issues related to cross-factory activities.
Update/Upload data, results, reports, etc., to each Factory’s ERP/Quality system, via their portal.
Support inspections and investigations related to OTCs.
Support special Regulatory requests as needed.
Support sharing and transmission of draft and approved OTC formulas, Batch Procedures, Specifications, etc.
Support new OTC projects and Line trials.
Any additional duties or assignments as directed by the Supervisor or QA Manager.
Familiarity with OTC/US FDA 21
CFR Part 210 & 211 and Cosmetic GMPs is required.
Minimum Qualifications:
Minimum of Associate or Bachelor degree (Life Sciences, Engineering, related profession).
Five+ years industry or related experience in cosmetic, device, food, or pharma.
Previous inspecting, auditing or manufacturing experience – a plus.
Data analysis, specification development skills.
Computer literate and effective communication skills.
Benefits:
Medical, Dental, and Vision Insurance
Life Insurance
401k match
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Title: OTC Program Coordinator
Company: Englewood Lab, Inc
Location: Totowa, New Jersey, USA
Category: Quality Assurance – QA/QC, Healthcare
