Quality Assurance Associate

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Job description

The QA Engineer is responsible to ensure that products manufactured for meet quality and compliance expectations. The product portfolio consists of Cosmetics and Personal Care Products. This position provides on-site oversight of the end to end manufacturing and associated operations.

This position will also provide risk-based QA direction, perspective and support to a range of technical, compliance and business issues pertinent to products and materials manufactured, tested and/or stored at the facility.Key Responsibilities:

All responsibilities listed below are specific to the specified contract manufacturing site.

* Strongly prefer experience with carrying out short and long-term remediation plans. Ensure that actions taken meet established commitments and create an improved future state
* Responsible to ensure overall compliant operations at the site. Routine presence on the shop floor is necessary.
* Review and approve site investigations, CAPA and all other quality systems documents
* Review and approval of batch records. .
* Provide expertise, oversight, mentoring, and guidance to the site where required to help develop expertise and drive competency development across the site.
* Monitor and react decisively to trends noted in the area of non-conformance events, CAPAs, and other quality/compliance indicators.
* Participate in routine meetings and track open actions through to completion.

Escalate issues immediately where there are quality issues which pose any risk to previously released materials.

Requirements

Education:

* A minimum of a Bachelor's degree is required.
* A focused degree in a Science related discipline is preferred.

Experience:

* A minimum of 2 years of experience working in a regulated industry is required.
* Pharmaceutical experience is requirred.
* Working knowledge of cGMP requirements, current FDA enforcement issues and current regulatory authority enforcement practices is required. Working knowledge of process validation, cleaning validation, manufacturing and packaging equipment train designs, microbiological controls, and assessing compliance to regulations is preferred
* Plant Quality experience is preferred.

* Experience in the facilitation of internal and external audits and regulatory inspections is preferred. cGMP
* Ability to lead cross-functional teams
* Technical writing skills
* Experience working with / collaboration with external suppliers

* Expertise in plastic components, process qualifications
* Expertise in evaluation of process reliability
* Expertise in site assessments
* Great communication skills
* Great data mining and analysis
* SOP development and or updates
* cGMP / GDP experience
* Ability to lead cross-functional teams
* Technical writing skills (in case of an INV)
* Experience working with / collaboration with external suppliers

Knowledge, Skills and Abilities:

* CAPA, complaint management, document management, supplier management and qualification, Quality agreements, change control, labeling, batch release
* Writing quality documents SOPs, Policies, work instructions
* Data analysis, collection, sorting

Benefits

A comprehensive benefits package including, medical, dental, 401k, PTO and life and disability insurance.