Planet Pharma ยท 5 hours ago
Quality Engineer II
North Haven, CT
Full-time
Onsite
Entry, Mid Level
2+ years expPlanet Pharma is focused on quality engineering support for the AMCOR Packaging Project, and they are seeking a Quality Engineer II to provide documentation support and coordinate validation quality testing. The role involves developing quality standards, collaborating with engineering and manufacturing, and ensuring compliance with quality assurance requirements.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
Collaborates with engineering and manufacturing functions to ensure quality standards are in place
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
Designs or specifies inspection and testing mechanisms and equipment; conducts quality assurance tests; and performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
Qualification
Required
Quality Engineering support for AMCOR Packaging Project
Documentation support
Execution of DR, IQ, PD, TMV, OQ, PQ, NCMR, CAPA, PFMEA /Risk Assessment
Coordination of all validation quality testing
Process Validation
Root Cause Analysis (CAPA, NCMR)
Statistical Analysis (Process Capability)
BS
2-3 years of experience
Develops, modifies, applies and maintains quality standards and protocol for processing materials into partially finished or finished materials product
Collaborates with engineering and manufacturing functions to ensure quality standards are in place
Devises and implements methods and procedures for inspecting, testing and evaluating the precision and accuracy of products and production equipment
Designs or specifies inspection and testing mechanisms and equipment
Conducts quality assurance tests
Performs statistical analysis to assess the cost of and determine the responsibility for products or materials that do not meet required standards and specifications
Ensures that corrective measures meet acceptable reliability standards and that documentation is compliant with requirements
May specialize in the areas of design, incoming material, production control, product evaluation and reliability, inventory control and/or research and development as they apply to product or process quality
Typically an individual contributor with responsibility in a professional discipline or specialty
Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results
May act as a mentor to colleagues or may direct the work of other lower level professionals
Established and productive individual contributor
Works independently with general supervision on larger, moderately complex projects / assignments
Sets objectives for own job area to meet the objectives of projects and assignments
Contributes to the completion of project milestones
May have some involvement in cross functional assignments
Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area
Communicates primarily and frequently with internal contacts
External interactions are less complex or problem solving in nature
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making
May provide guidance and assistance to entry level professionals and/or employees in Support Career Stream
Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience
Requires a University Degree and minimum of 2 years of relevant experience
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
1001-5000 employees
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Cynthia Lewis
Senior Executive Recruiter, Life Sciences - PPG Advisory Partners
Emma Morris
President, PPG Advisory Partners
Company data provided by crunchbase