Planet Pharma · 11 hours ago
Mfg/Ops Quality Engineer 2
San Diego, CA
Full-time
Onsite
Mid Level
$35.50/hr - $44.25/hrPlanet Pharma is focused on manufacturing and product quality activities, and they are seeking a Quality Engineer 2 to support day-to-day sustaining activities in a manufacturing environment. This role involves collaboration with engineering and manufacturing teams to ensure quality compliance and continuous improvement in manufacturing processes.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Provide ongoing quality engineering support throughout the product life cycle
Provide support to engineering and manufacturing functions for validation planning and transfer activities. Assist teams in determining validation needs and requirements
Ensures adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions
Support process risk management activities and ensure quality and completeness of validation packages, and change orders
Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making
Review verification and validation reports and identify gaps for GMP compliance
Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
Coordinate issue resolution using a risk-based approach
Ensure manufacturing processes and validation programs meet requirements of FDA and ISO
Trend, analyze, and report on quality data in order to improve product and process; develop recommendations based on data analysis
Collaborate with counterparts and cross-functional teams at other sites
Other activities as assigned
Qualification
Required
Exceptional communication skills
Exceptional interpersonal skills
Exceptional project management skills
Support day to day sustaining activities in a manufacturing environment
Direct interaction with Manufacturing and Process Engineering groups
Support manufacturing sustaining activities
Support continuous improvement
Support manufacturing capacity expansion
Quality oversight for more than one manufacturing area
Support change management activities
Manage Nonconformances
Manage equipment lifecycle
Facilitate meetings
Provide ongoing quality engineering support throughout the product life cycle
Support engineering and manufacturing functions for validation planning and transfer activities
Assist teams in determining validation needs and requirements
Ensure adequacy of non-conformances and QI/CAPA records, investigations, and corrective actions
Support process risk management activities
Ensure quality and completeness of validation packages and change orders
Become familiar with applicable technology for technical discussions and risk-based decision making
Review verification and validation reports and identify gaps for GMP compliance
Develop and execute strategies to close gaps in an efficient, technical, and compliant manner
Coordinate issue resolution using a risk-based approach
Ensure manufacturing processes and validation programs meet requirements of FDA and ISO
Trend, analyze, and report on quality data to improve product and process
Develop recommendations based on data analysis
Collaborate with counterparts and cross-functional teams at other sites
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
Founded in 2009
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