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Quality Engineer (Sterile Products)

  • Anywhere

Company :
StarrTrax

Location :
Lebanon, Pennsylvania

Expiry Date :
Sun, 13 Jun 2021 23:59:59 GMT

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Description :
QUALITY ENGINEER

POSITION: Quality Engineer (Sterile Products)

COMPANY:SCHOTT Pharmaceutical Packaging (Lebanon, PA) is a division of SCHOTT North America and is one of the most respected suppliers of high quality glass tubing containers for parenteral products in North America. SCHOTT PPP offers technological leadership and innovation as well as outstanding customer care for both local and multi-national clients, whether it is packaging for liquid, lyophilized or powder products.

COMPENSATION: 80,000 to 100,000

ATTRACTIVE SKILLS/EXPERIENCES:

* BS Degreein Chemistry, Microbiology or related technical field (required)
* Experience (5+ years) in quality engineering with sterile products (ETO sterilization preferred)
* Experience (3+ years)in product/process investigations, validations, instrument qualifications and Environmental Monitoring (EM) programs
* Demonstrated knowledge of ISO 11135
* Demonstrated knowledgeof ISO 9001 and ISO 15378; along with cGMP
* Experience in the glass forming industry and/or pharmaceutical industry experience (preferred)
* Demonstrated knowledge and experience using MS Office applications and SAP and Minitab
* Demonstrated technical writing and communication skills
* Demonstrated communication skills (written / oral) including the ability to read/speak English
* Ability and willingness to work in an office setting with moderate noise
* Ability and willingness to work in fast-paced, matrix structured organization
* Ability and willingness to work traditional Mon-Fri work week (8am 5pm) w/ flexibility

SUMMARY / RESPONSIBILITIES: This Quality Engineer will plan, coordinate and implement quality projects related to Sterile production, to include; product/process investigations, validations, instrument qualification and Environmental Monitoring (EM) programs. Perform in-depth analysis and reporting to foster continuous improvements measures and initiatives. In addition, help define and implement short and long-term strategies to achieve departmental goals and site objectives, while reporting on Key Performance Indicators (KPI), when applicable. Other essential functions include (but are not limited to):

* Validation and re-validation of Sterile processes, including new cycle development with contractor(s)
* Lead regional or customer led improvement activities and support applicable roll-outs
* Perform trending and monitoring of relevant quality KPIs pertaining to Sterile products and related quality aspects; and implement improvement measures accordingly
* Assure compliance with ISO certifications (ISO 9001, ISO 15378) and cGMP, along with adherence to Company policies and procedures and Code of Conduct
* Coordinate Environmental Monitoring (EM) program and seek potential enhancement measures to the program
* Support the laboratory side of engineering method and equipment validation/qualification initiatives
* Manage and trend data from EM, process, raw materials and finished product testing
* Perform site based risk assessments
* Monitor and support the proper implementation of change controls
* Support quality control plan analysis and improvements, to include packaging development and execution of related projects and action items
* Coordinate, collect and analyze quality data for customers; troubleshoot and resolve customer issues; provide root cause analysis and correct/preventative actions to eliminate reoccurrences
* Manage assigned CAPA(s) by performing root cause investigations, while defining resolution actions; implement preventative and corrective actions in a timely manner as a result of customer complaints or customer audit findings
* Support experimental and validation protocols for equipment, processes and materials, while designing protocols, performing tests and completing technical reports
* Develop and document best practice methods; ensure standardized procedures
* Perform other duties as assigned