Gmp Coordinator I - San Diego, United States - Revvity

Revvity

Verified Company

San Diego, United States

3 weeks ago

Posted by:

Mark Lane

beBee recruiter

Description

Job Summary

While the role is a "Day Shift*", it is anticipated that production runs may be required to start earlier in the day or end later in the day than a standard Day Shift.

The coordinator is required to have a flexible schedule and be able to support earlier or later schedules and, as needed, be available for Saturday or Sunday shifts, with as much advance notice as is practical for the business.

This is a highly team-oriented group that involves working closely with all core teams within the GMP Department as well as other departments such as Quality Assurance, Product Development, Planning, Purchasing, Receiving, Inventory Control, Custom Solution Team (CST), Packaging and Quality Control groups.

Essential Functions
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Follow all safety, GMP, quality management system, and company policies and procedures
Maintain all batch records and other documentation that are essential to be in compliance with ISO13485:2016 and MDSAP regulations
Coordinate work according to the schedule provided by various business functions such as manufacturing, planning, product and process development, and custom service teams
Act as a liaison and active problem solver for various business functions, positively and successfully addressing any scheduling conflicts and constraints that may impact our ability to deliver highquality products, on time and in the required quantities
Perform preparation work for scheduled orders to ensure that they are started on time
Ensure orders are completed, from planning start date, through production execution, to final QC and QA release to finish goods inventory, with an "Ontime Delivery" target (OTD) of >99%
Maintain laboratory equipment such as ensuring equipment is calibrated and approved for use ahead of the production start dates, and is available for processing orders
Coordinate the maintenance, collaboration, and validation schedules with Manufacturing, Process Engineering, Facilities and Planning teams, and other stakeholders to ensure no disruptions to production order execution, e.g. prevent delays
Review, manage, and count laboratory supplies, reconciling and cycle counting as required, including conducting monthend cycle counts
Receiving materials and conducting receiving inspection, organizing/labeling, and updating logs
Printing and inspecting labels for final product production
General buffer preparation, formulation, and dispensing
Washing lab glassware
Data entry and production documentation completion tasks
Perform internal audits
Be a key member of the GMP audit team including internal, external, customer, and 3rd party quality management system audits
Collect data and create routine reports for relevant departments e.g. monthly reports
Various other tasks to ensure the productions run smoothly
Supplement production output, be handson, to meet changing inventory and customer needs, and to stay updated on manufacturing processing techniques
Other projects or responsibilities as may be required

iACT Competencies
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innovate

Be better, keep improving, be more efficient, creative, and be in the forefront of development

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Aspire

Have desire, purpose, and ambition challenging ourselves to push the limits and reach new heights

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Collaborate

Foster teamwork, common goals, selflessness, communication and mutual support

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Transform

Adapt, learn, reinvent and change for future development and growth

Minimum Qualifications -
Education and Experience

6 months of relevant experience in a laboratory, biotech manufacturing, and/or filling/bottling/packaging working environment

Preferred Qualifications - Education and Experience

Associate's Degree in Biology, Biochemistry, Chemistry, or other related area
2+ years of work experience in Biotechnology or life science industries and working knowledge of quality management systems including ISO 13485, MDAP, or cGMP regulations
Demonstrated experience in the planning, coordination, and execution of complex production schedules with a 99%+ OTD
Demonstrated ability to be detailoriented, and organized, work well in small work groups, and adhere to timelines
Advance pipetting skill
Practical knowledge of planning, coordination, and execution of production or other schedules
Knowledge of Good Documentation Practices (GDP)
Knowledge of aseptic techniques in biosafety cabinets
Ability to perform simple math calculations
Ability to communicate effectively both orally and in writing with a broad crosssection of stakeholders, from frontline employees, and senior management, to external parties e.g. vendors and customers
Experience with Enterprise Resources Planning (ERP) and/or Materials Requirements Planning (MRP) software
Experience with raw material supply receiving and inspection processes

**Work Env