What are the responsibilities and job description for the Production Operator-Senior position at Equiliem?
Summary
The Operations Specialist position is responsible for performing production activities in compliance with applicable government regulations and guidelines as well as with company policies and procedures.
Essential Functions
* Successful completion of the training requirements associated with the execution of activities within the production function. GMP's; Safety; Policies and procedures necessary to perform the assigned tasks in the functional area for which proficiency has been achieved.
* Execute day-to day activities related to the ongoing production function. These tasks include: cylinder prep, bake-out, blow-down, filling and packaging of finished drug products.
* Perform daily operations schedule; Communicate with functional Leads and Quality Assurance concerning schedule changes that may impact production requirements and QA coverage. Process staging requirements, segregation, documentation, and safety requirements; Execute the weekly schedule as required to meet production demands.
* Comply with the applicable Production Batch Records and Procedures; Review applicable Batch Records and Procedures to ensure compliance with policy, procedures and GMP's requirements. Procure components to support applicable manufacturing operations.
* Conduct an inventory of components and parts in your area of responsibility to ensure there is no interruption in the production schedule. Perform daily review of all logbooks to ensure compliance and completion as required per procedure.
* Execute equipment cleaning and preventive maintenance procedures as required within the Manufacturing area.
* Assist throughout the production department as required. Assure proper housekeeping of all facilities according to established procedures.
Minimum Requirements
Education / Experience / Skills:
* High school diploma required, PTEC degree preferred.
* Technical background in Chemistry or Compressed Gases with 2 years' experience working in a manufacturing environment preferred. Prior exposure within a manufacturing environment subject to FDA requirements preferred.
* Knowledge of CGMPs
Competencies:
* Computer literacy in Excel and Word is a required
* Good written and oral communication
* Strong leadership skills with a results oriented approach as well as the ability to train, motivate, and otherwise develop resources.
* Experience using ERP system such as SAP is preferred.
Organizational Relationship/Scope:
Officially supervised by Manufacturing Supervisor. Informally managed by Lead Operations Specialist within given functional area.
Working Conditions:
Current work schedule is four 10 hour days per week, but subject to change. Work is mostly performed indoors. Occasional periods of work outdoors required.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion, color sex, national origin, citizenship status, age, sexual orientation, gender identity, marital status, uniform service member status, genetic information, disability, or any other protected status, in accordance with all applicable federal, state, and local laws. This practice extends to all aspects of our employment practices, including but not limited to, recruiting, hiring, firing, promoting, transferring, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.
The Operations Specialist position is responsible for performing production activities in compliance with applicable government regulations and guidelines as well as with company policies and procedures.
Essential Functions
* Successful completion of the training requirements associated with the execution of activities within the production function. GMP's; Safety; Policies and procedures necessary to perform the assigned tasks in the functional area for which proficiency has been achieved.
* Execute day-to day activities related to the ongoing production function. These tasks include: cylinder prep, bake-out, blow-down, filling and packaging of finished drug products.
* Perform daily operations schedule; Communicate with functional Leads and Quality Assurance concerning schedule changes that may impact production requirements and QA coverage. Process staging requirements, segregation, documentation, and safety requirements; Execute the weekly schedule as required to meet production demands.
* Comply with the applicable Production Batch Records and Procedures; Review applicable Batch Records and Procedures to ensure compliance with policy, procedures and GMP's requirements. Procure components to support applicable manufacturing operations.
* Conduct an inventory of components and parts in your area of responsibility to ensure there is no interruption in the production schedule. Perform daily review of all logbooks to ensure compliance and completion as required per procedure.
* Execute equipment cleaning and preventive maintenance procedures as required within the Manufacturing area.
* Assist throughout the production department as required. Assure proper housekeeping of all facilities according to established procedures.
Minimum Requirements
Education / Experience / Skills:
* High school diploma required, PTEC degree preferred.
* Technical background in Chemistry or Compressed Gases with 2 years' experience working in a manufacturing environment preferred. Prior exposure within a manufacturing environment subject to FDA requirements preferred.
* Knowledge of CGMPs
Competencies:
* Computer literacy in Excel and Word is a required
* Good written and oral communication
* Strong leadership skills with a results oriented approach as well as the ability to train, motivate, and otherwise develop resources.
* Experience using ERP system such as SAP is preferred.
Organizational Relationship/Scope:
Officially supervised by Manufacturing Supervisor. Informally managed by Lead Operations Specialist within given functional area.
Working Conditions:
Current work schedule is four 10 hour days per week, but subject to change. Work is mostly performed indoors. Occasional periods of work outdoors required.
We are committed to providing equal employment opportunities to all employees and applicants without regard to race, religion, color sex, national origin, citizenship status, age, sexual orientation, gender identity, marital status, uniform service member status, genetic information, disability, or any other protected status, in accordance with all applicable federal, state, and local laws. This practice extends to all aspects of our employment practices, including but not limited to, recruiting, hiring, firing, promoting, transferring, compensation, benefits, training, leaves of absence, and other terms and conditions of employment.
