Pc Refresh Technician

West Point Quality Operations is seeking a highly motivated individual to provide complaint investigation support for vaccine manufacturing. The primary focus of the role is customer complaint investigation. The role may also include process improvements, batch data analysis, and support for regulatory inspections. Specific assignments may be focused in one operational area or span multiple areas.

The individual in this position will be responsible for the following (not all inclusive):

• Performing investigations and second person review for customer complaints aimed to prevent recurrence, including determining the root cause, identifying
• Corrective/Preventative actions (CAPAs), identifying event scope, and conducting product impact assessment. Where applicable, complete investigational test protocols to
• determine root cause, product impact, event scope, etc.
• Authoring notifications to applicable Health Authorities, in response to complaints, as required.
• Supporting the customer complaint work-in-progress at tier meetings/huddle, including
• assigning of workload and managing all relevant complaints trackers
• Complaints Governance meeting, Complaints Community of Practice (COP), and Health
• Authority Assessment meeting to evaluate complaints, facilitate the discussions to align with Technology and Quality approvers / representatives and site leadership.
• Collaboration across IPT functional areas to drive robust processing and continuous improvement. Continuous improvement may include proactive process improvements and investigation CAPAs.
• Retention sample and batch record evaluation as applicable.
• Drafting/review/support of Biological Product Deviation Reports (BPDR) and Adverse Event Quality Inspection Reports (AEQIRs).
• Supporting team and site safety, environmental, and compliance objectives.
• Actively using and championing the use of our Company Production System tools, both in problem solving and day-to-day complaint activities, Business Valuation Full Stack Development Artificial Intelligence Business Transformation Troubleshooting (Problem Solving) Microsoft Intune (Mobile Device Management Software) +0 Shop Helper Aerotek

Souderton, PA*On-Site

Aviation Painting Machinery Hand Tools Health Advocacy Artificial Intelligence Overhead Crane Operation Discounts And Allowances Employee Assistance Programs +0 Manager Aerotek

Ewing, NJ*On-Site

Operations Management Governance Innovation Compassion Adaptability QC Reporting Data Analysis Life Sciences Investigation Pharmaceuticals Self-Motivation FDA Regulations Problem Solving Decision Making Quality Control Telephone Skills Impact Assessment Biopharmaceuticals Project Management Aseptic Processing Process Improvement Progress Monitoring Contingent Workforce Deviation Management Competency Management Internet Protocol Telephony Good Manufacturing Practices Customer Complaint Resolution Continuous Improvement Process Troubleshooting (Problem Solving) Corrective And Preventive Action (CAPA), * Bachelor’s degree*. Degree in Life Sciences, Science discipline, or Engineering field (preferred); candidates with degrees in other fields will be considered if accompanied by significant relevant experience.

• • In lieu of Bachelor’s degree as described above, equivalent direct experience of minimum 4 years of work experience in GMP Manufacturing or Laboratory environment or regulatory function.

Required Experience:

• Minimum 1 year of relevant post-degree work experience in GMP Manufacturing or Laboratory environment, Pharmaceutical/Biological Quality, Operations, Technical, or Regulatory function supporting manufacturing or Laboratory Operations, or related industry experience.

Preferred Experience and Skills:

• Customer Complaint investigator or previous complaints support
• Prior Deviation Management investigator
• Experience in biologics, vaccine, or bulk sterile manufacturing facilities.

Required Skills: Adaptability, Adaptability, Aseptic Manufacturing, CAPA Management, cGMP Compliance, Competency Management, Customer Complaint Management, Customer Complaint Resolution, Data Analysis, Decision Making, Documentation Review, Environmental Stewardship, Equipment Troubleshooting, FDA Regulations, Interpersonal Relationships, Laboratory Operations, Laboratory Quality Control, Operational Quality, Process Improvements, Progress Monitoring, Project Management, Quality Inspections, Quality Operations, Quality Reporting, Records Review {+ 8 more}, Curiosity Upselling Chemistry Operations Leadership Management Cleanliness Phone Sales Coordinating Cross-Selling Detail Oriented Problem Solving Medical Devices Health Advocacy Customer Service Customer Support Technical Support Performance Review Influencing Skills Industry Standards Ultrasonic Cleaning Performance Testing Proposal Development Demonstration Skills Operations Management Artificial Intelligence Technical Documentation New Business Development Employee Assistance Programs Influencing Without Authority Cross-Functional Collaboration Troubleshooting (Problem Solving) +0

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is $87,300.00 - $137,400.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.