Senior Specialist Quality Assurance

2 weeks ago

Jersey City, United States Spectraforce Technologies Full time
Title: Senior Specialist Quality Assurance - Level III (Senior)

Location: 100% Remote

Duration: 12 Months with possibility of extension

Qualifications:

* Education: BS/MS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) with minimum 5 years of relevant experience within Quality Systems, Quality Assurance, and Quality Control.

* Previous experience within the pharmaceutical industry or Medical Devices Combination Products with thorough knowledge of Quality Systems, Quality Assurance, and Quality Control.

* Must have working knowledge of regulatory expectations for the manufacture and/or testing of pharmaceutical products and/or Medical Devices Combination Products, with experience in quality, manufacturing, process validation and/or process technology transfer processes.

* Excellent technical, organizational, interpersonal, collaborative, and verbal/written communication skills.

* Experience with Quality functions supporting release and compliance activities or indirect involvement in Quality functions through execution of activities such as batch record/documentation reviews, investigations, corrective actions, complaints, quality system management, etc.

Required Skills:

* Must have ability to make assessment of technical reports (example: investigations, product release) and determine acceptability based on organizational requirements.

* Must be able to handle multiple priorities at a time and immediately address urgent issues.

* Solves complex problems; takes a new perspective using existing solutions.

* Accountable for medium sized projects with minimal resource requirements, risk and/or complexity.

* Works independently, receives minimal guidance.

* Experience with administration and data entry of technical reports into internal databases.

* Explains difficult issues and works to build alignment around a complex situation.

* Ability to work across boundaries; demonstrated interpersonal, relationship building and leadership skills.

* Strong knowledge of External Manufacturing management, supply chain, and operations.

* Communicates easily in English both verbally and in writing.

* Lean Six Sigma Systems training is an advantage.

* Fluent in English language (reading, writing, and speaking)

Softwares:

* Knowledge and competency with various IT systems, including Comet-SAP, Midas (document storage system), Track Wise Complaints system (QCC4), and Trackwise Change Control (GCM).

Responsibilities:

Primary Activities may include, but are not limited to the following:

* Evaluate and release products to other sites with the assurance that the goods were produced in conformance to all applicable policies/procedures and compliance with all governing regulations.

* Manage routine and complex deviations and complaints and assist in the coordination of significant investigations; assist in the coordination of report closures required by the external manufacturer.

* Support routine and complex change requests and support process modification change controls.

* Provide guidance in the preparation of metrics, procedures, and guidelines; provide proactive support in training and coaching to initiate quality improvements.

* Track and monitor operational and quality performance of the external manufacturer and work with supplier to develop CAPA plans, as needed.

* Gather, interpret, and report, in a timely manner data for internal Annual Product Review (when required).

* Participate with site visits to build relationships and monitor efforts to improve the external manufacturer's quality and reliability through ongoing oversight and formal communication programs and forums.

* Acts as a resource for colleagues with less experience within own discipline; can provide minimal guidance on issue resolution and act as Subject Matter Expert (SME)

Comments/Special Instructions

Note: If you are using AgileOne Resume format to submit your candidates, please make sure you remove this line from the resume and submit: "Merck previous experience: (contract/FTE)".

Organon and Merck are both different clients, they are not part of each other since 2019.

Key skills:

* Complaint investigation experience within the medical device.

* Medical device industry or medical device experience within pharmaceutical industry or Medical Devices Combination Products.

* Deviation management, investigations and CAPA.

* Experience with complaint management system like TrackWise.

* Experience in regulated environment.

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