...a clean room environment
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required... ...testing (ex. bioburden, endotoxins), and microbiology laboratory investigations.
Strong technical writing skills are required, as this...
...billing for tax allocation purposes under guidance of a manager.
Significant work activities:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Frequent to continuous computer usage (greater or equal to 50% of the...
...integrity, quality, adequacy, and appropriateness of validation documentation through comprehensive document review.
Ensure thorough investigation and timely resolution of issues related to equipment, facilities, and utilities.
Manage validation related, quality...
...other program applicable according to the position duties.
Significant work activities:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hr day) is required
Continuous standing for prolonged periods (more than 2 consecutive hours...
...functionally and effective communication within the EHS Department while ensuring that information is timely, clear and accurate.
~ Investigate and prepare required reports of EHS system performance including but not limited to investigation reports, injury reports,...
...negotiations, day-do-day troubleshooting and problem resolution, managing the on-going relationships and communication, performing periodic benchmarking of the subvendor population, etc.). Additionally responsible for maximizing customer satisfaction, maintaining and...
...how they are applied to regulatory compliance.
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
~Creating long- and...
...business processes, as well as the involved project management.
Job Description
The resource is responsible on managing process investigations, evaluates deviations with respect to their causes and corrective actions to prevent recurrence
Investigations.
Root...
...Compressed Air, and so forth)
~Project Management competencies
~Must be fully bilingual (English / Spanish) with excellent oral skills.
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays....
...For Investigations s ervices in the Quality and Utilities area.
WHAT MAKES YOU A FIT:
The Technical Part:
Bachelor’s degree in... ...~ Report on critical & key performance measurements. Submit periodic task reports to management.
~ Mentor, develop and train peer...
...technical matters related to troubleshooting, manufacturing investigations task items, CAPA’s, Change Controls, Stand Alone Actions.
•... ..., LOSM, SC, etc.). Also works with minimum supervision, with periodic monitoring and review of results.
CONTACTS Describe the most...
...operations areas.
~ Ensures that deviation on documentation dealing with OOS or process parameters outside filing or validation are investigated and resolved by thoroughly reviewing timely corrective actions.
~ Provides key technical guidance and oversight to...
...ruggedness and robustness processes.
Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control.
Coordinates projects to assure...
...batch records, forms, protocols, procedures, qualification, and validation reports. Enforce critical analytical thinking in the investigation management process specifically during root cause analysis, risk assessment evaluation and corrective and preventive actions determination...
...English.
Experience in:
Federal and Commonwealth rules and regulations.
MS Office.
EHS Assessments programs and incident investigations.
Permits and Reports.
The Personality Part:
~ If you have a commitment to serving customers with high-quality...
..., presentations and reviews data to monitor product processing activities.
6. Leads and participates in out-of-trend product investigations with Senior Product Scientists and represents processing area as requested in fact finding meetings.
7. Leads process robustness...
...control procedures and best practices.
~Provide training and support to employees on document control processes and systems.
~Conduct periodic audits of document control processes to identify areas for improvement and ensure compliance.
Requirements:
~Bachelor's degree...
...commercial and contractual origin; contract negotiations; project planning, and risk management as well as supervising and implementing periodic reviews of sales and operational activities.
Responsibilities:
~Execute the sales, service and marketing strategies established...
...una red de contactos “networking”, y las siguientes destrezas; de persuasión, de prospectar, de hablar en público, de proceso de investigación, de negociación y cierre, de planificación, de identificación de necesidades del cliente, y de manejo de objeciones. Motivado y...
...Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays....
...Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays....
...ruggedness and robustness processes.
#Supports the Analytical Ruggedness Project Manager and Quality Control to gather information on investigations, troubleshooting, method deviations, method optimization, and method change control.
#Coordinates projects to assure...
...how they are applied to regulatory compliance.
~Strong knowledge (according to related area).
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
~OOS Lead Investigator...
...product and computer systems validation protocols and reports, change control documentation, reprocessing / rework operations, investigation reports related to manufacturing process and analytical and microbiology laboratory.
Review/Approve equipment/facilities/system...
...agencies.
#Maintains statistics, develops reports and files official reports with regulatory agencies.
#Administers the incident investigations program to determine rood cause and develop action plan to avoid recurrence and follows-up to ensure improvements are made....
...(CMMS) for work management processes, with proficiency in SAP CRM, Blue Mountain RAM, Maximo or ProCal preferred.
# Coordinate periodic business review meetings with key stakeholders to discuss asset management strategies, address concerns, and identify opportunities...
...Qualifications, Risk Assessments, Traceability Matrix and IQ, OQ, PQ protocols development and execution, deviations and reports generation
~Technical Writing skills and investigations processes.
~Available to work extended hours, possibility of weekends and holidays....