Senior Specialist Quality Assurance - Level II (Associate)
One Merck Drive (PO BOX 100) Kenilworth, NJ 07033 US
Target Pay Rate 25-32.79/hr **salary will be commensurate with experience
- 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.
- 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.
- Knowledge and competency with various IT systems, including Comet-SAP, Midas (document storage system), Track Wise Complaints system (QCC4), and Track Wise Change Control (GCM). Accountable for medium sized projects with minimal resource requirements, risk and/or complexity.
- May act as a team or project lead and lead work of others as required; promotes teamwork and open discussion of issues, coaches and guides others.
- Strong knowledge of External Manufacturing management, supply chain, and operations.
- 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) Communicates easily in English both verbally and in writing.
- Lean Six Sigma Systems training an advantage.
- Fluent in English language (reading, writing and speaking)
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.
- Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent)
- Previous experience within the pharmaceutical industry 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.
**CO/NY candidates may not be considered
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.