Test Lead overseeing testing activities to ensure software quality and mentoring team members. Collaborate with project stakeholders and recommend process improvements for testing efficiency.
About the role
- Quality Engineer ensuring compliance with quality practices and leading investigations at Leiters Health. Performs inspections, develops quality control policies, and collaborates with cross-functional teams.
Responsibilities
- Lead investigations for quality events, deviations and complaints
- Review and assist with implementation of changes through the change control process.
- Lead and assist with internal audits through the internal audit program.
- Assist with regulatory inspections and serve as Subject Matter Expert (SME) related to quality systems including deviations, CAPAs, change controls, etc.
- Implementing methods to inspect, test and evaluate the reliability of the manufacturing processes, products, and product equipment
- Prepare and deliver on time investigation reports by collecting, analyzing, and summarizing data
- Serve as Subject Matter Expert (SME) and ensure compliance with integrity of BMRAM system staying current with quality reviews and improving timeliness of equipment calibration.
- Provide quality guidance, expertise, and services in collaboration with all departments to ensure decisions for processes, data and product are quality driven, compliant to batch records, operating procedures, and regulatory requirements.
- Engage in cross-functional team discussions for issue resolution, process improvements and/or triage and initiate event records.
- Partner with peers to ensure alignment on issue resolution, decisions for processes, and compliance to batch records.
- Create, revise, and author documents and deviation records.
- Perform trending reports.
- Assist with 503B regulatory activities such as state regulatory reporting, DEA record keeping and diversion investigations.
- Other duties as assigned.
Requirements
- Bachelor’s degree in relevant field or equivalent experience required.
- 3+ years of quality experience required, preferably in a regulated industry.
- Knowledge and experience of compounding techniques and controlled environments is preferred.
- Knowledge of appropriate materials and conditions is preferred.
- Ability to identify potential adverse issues.
- Excellent organization and documentation skills.
- Demonstrated ability to solve problems of limited scope and complexity, seeks management guidance as required.
- Collaborative spirit, able to work with a team to ensure that the systems involved in a 503B outsourcing facility are in a state of control.
- Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!
- Proficient written, verbal and oral English communication skills are required.
- Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.
Benefits
- Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)
- Flexible Spending & Health Savings Accounts (FSA & HSA) available
- Dental & Vision insurance
- Employer Paid Life Insurance & Employee Assistance Program
- Short Term & Long-Term Disability Insurance
- Up to 4% 401K Matching (100% vested on day one!)
- Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
- $5,250 Annual Tuition Reimbursement after 6 months
- $1,000 Referral Bonus Program with no limit
- Eligible for annual bonus program
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Join Octal Philippines Inc. as an Automation Tester ensuring software quality. Collaborate with teams to enhance software testing efficiency and implement automated solutions.
Senior QA Engineer at Advanced Solutions International ensuring quality in enterprise software solutions. Collaborating with cross - functional teams in an Agile environment to deliver high - quality products.
Cyber Security Consultant conducting security assessments and delivering consulting services for both local and international clients. Engaging in a variety of security projects and training.
Quality Engineer responsible for continuous improvement and quality processes in an industrial metal company in Alsace. Focused on audits, corrective actions, and client non - conformities.
Quality Engineer advising on feasibility in print processes and quality management in production. Collaborating with sales, production, and suppliers to prevent errors while ensuring quality standards.
Quality Engineer at G+D improving and ensuring quality standards in printing processes. Collaborating with various departments and supporting audits and certifications in an international environment.
QA Analyst testing next - generation FTB platforms within the Techhub Agile team. Designing and executing tests, investigating issues, and contributing to product development.
SQA Engineer focusing on software verification of medical products in a hybrid work environment at KARL STORZ. Collaborating with global stakeholders to ensure compliance and quality standards.
Quality Engineer responsible for assuring quality in production across two sites in Germany. Focused on quality planning, supplier management, and process evaluations with a critical technical understanding.