Planet Pharma
https://cdn.haleymarketing.com/templates/63514/logos/square.png
https://www.propharmagroup.com
https://www.propharmagroup.com
true
Target Pay Rate: 35.50-44.25/hr **salary will be commensurate with experience
Position Summary:
This position is responsible for manufacturing and product Quality activities including direct interaction with the Manufacturing and Process Engineering groups to support manufacturing sustaining activities continuous improvement and manufacturing capacity expansion. This role is within Mfg/Ops Quality organization and is accountable for driving change establishing sustainable processes improving products providing actionable process and product data supporting risk management activities and development of process/product validation strategies and sharing best practices. This position works on problems of limited scope follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained builds stable working relationships internally to effectively coordinate activities completes assigned actions on time according to plan proactively communicates challenges in advance of due dates requires strong communication provides supporting data to project lead on risk in area of responsibility delivers results and applies quality regulations and standards 21CFR 820 ISO 13485 ISO 14971 IVDD MDD where appropriate.
Responsibilities:
Requirements:
Experience/Education:
Mfg/Ops Quality Engineer 2
5200 Illumina Way San Diego, CA 92122 US
Posted: 11/21/2024
2024-11-21
2025-01-02
Employment Type:
Contract
Job Category: Engineering
Job Number: 615995
Is job remote?: No
Country: United States
Job Description
Target Pay Rate: 35.50-44.25/hr **salary will be commensurate with experience
Position Summary:
This position is responsible for manufacturing and product Quality activities including direct interaction with the Manufacturing and Process Engineering groups to support manufacturing sustaining activities continuous improvement and manufacturing capacity expansion. This role is within Mfg/Ops Quality organization and is accountable for driving change establishing sustainable processes improving products providing actionable process and product data supporting risk management activities and development of process/product validation strategies and sharing best practices. This position works on problems of limited scope follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained builds stable working relationships internally to effectively coordinate activities completes assigned actions on time according to plan proactively communicates challenges in advance of due dates requires strong communication provides supporting data to project lead on risk in area of responsibility delivers results and applies quality regulations and standards 21CFR 820 ISO 13485 ISO 14971 IVDD MDD where appropriate.
Responsibilities:
- Provide ongoing quality engineering support throughout the product life cycle.
- Provide support to manufacturing functions for validation planning and transfer activities.
- Ensures adequacy of non-conformances and CAPA records investigations and corrective actions.
- Become familiar with the applicable technology to facilitate participation in technical discussions and risk-based decision making.
- Review equipment onboarding calibration and preventative maintenance tickets and identify potential gaps for GMP compliance.
- Review change requests/notices/approvals for compliance to change requirements outlined in applicable WIs/Procedures.
- 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 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.
- Provide management with status updates on assigned responsibilities and goals and escalate issues in a timely fashion.
- Collaborate with counterparts and cross-functional teams at other sites.
- Other activities as assigned.
Requirements:
- A minimum of 0 to 2 years Mfg/Ops QE1 or 2 to 4 years Mfg/Ops QE2 of applied experience in the quality assurance field in a regulated environment direct experience working in in-vitro diagnostic manufacturing is desirable.
- Strong communication facilitation planning problem-solving and organizational skills.
- Demonstrated effective collaboration skills with teams in multiple/global locations is desired.
- Demonstrated ability or aptitude to learn how to manage and lead change.
- Good judgment and decision-making skills knows how to make trade-off decisions while balancing compliance and business impact.
- Experience with quality and process improvement methodologies and tools desired.
- Flexible with ability to work effectively in a fast-paced dynamic environment with shifting and competing demands.
- Ability to execute strategy approach methods and actions on new assignments.
- Is considered a subject matter expert for assessing and resolving complex quality issues.
- Applied experience in meeting and applying quality regulations and standards 21CFR 820 ISO 13485 ISO 14971 MDD IVDD and CMDR desired.
- Experience with data mining trend analysis and statistical analysis.
- Experience with electronic product life cycle PLM enterprise resource planning tools ERP manufacturing execution systems MES.
- Experience with enterprise Quality System tools e.g. electronic CAPA/NC Change Management systems.
- Background in oligonucleotide synthesis and surface activation chemistry a plus.
- Listed responsibilities are an essential but not exhaustive list of the usual duties associated with the position. Changes to individual responsibilities may occur due to business needs.
Experience/Education:
- Bachelors degree in an engineering or scientific discipline.
- Work experience in a quality engineering role desirable.
Share This Job:
Related Jobs:
Login to save this search and get notified of similar positions.About San Diego, CA
Ready to embark on an exciting career journey in sunny Southern California? Explore our job opportunities in the thriving city of San Diego! Known for its stunning beaches, perfect weather, and vibrant culture, San Diego offers a unique combination of career growth and quality of life. With renowned attractions like Balboa Park, the San Diego Zoo, and the USS Midway Museum, along with a diverse culinary scene and a plethora of art galleries and theaters like the La Jolla Playhouse, there's always something new to experience. Whether you're a sports enthusiast looking to cheer for the Padres at Petco Park or seeking outdoor adventures at Torrey Pines State Natural Reserve, San Diego has something for everyone. Begin your job search today and discover why this picturesque city is the perfect place to elevate your career!
Although this hasn't been an issue at Planet Pharma, 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 Planet Pharma.
