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SUMMARY
Under the direction of a Manufacturing Supervisor, directs employees' activities within an assigned manufacturing room or areas to package pharmaceuticals. Leads the assigned packaging associates to run validated processes to achieve established production schedules. Takes complete responsibility for the product quality, resource utilization, operational efficiency and employee safety within the assigned packaging room. Assist supervisor to ensure that all processes utilized and products packaged conform to customer and Company standards and specifications.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: will be assigned to a line/area as a production person; (usually the supply person). Other duties may be assigned.
Communicates supervisor's job orders to employees.
Get machines started efficiently.
Call a mechanic when the machine is down.
Recheck components brought onto the line by the material handler against the batch record.
Call a material handler to restock the line.
Check quality, lot number and expiration date while the job is running.
Ensure 200 % inspection forms are completed, as required.
Ensure all batch record entries, including daily room checks are performed.
Assist with lot changes by counting components for accurate accountability.
Calculates and records counts as required.
Maintain line/area in an orderly and safe manner while maintaining GMPs.
Notify supervisor with personnel issues.
Reports downtime on appropriate form.
Observe packaging operations for optimum performance.
Recommend measures to improve production methods, equipment performance, and quality of product.
Assist supervision with reporting the production performance metrics.
Suggest changes in working conditions and use of equipment to increase efficiency of work crew.
Responsible for training the designated peers as a replacement. This is completed at management's request.
SUPERVISORY RESPONSIBILITIES:
Responsible for notifying production supervisors of performance, policy and personnel issues, but not accountable for enforcement of policy.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be reliable and have an excellent attendance record.
EDUCATION and/or EXPERIENCE:
Preferred 4 year BS, BA or BT degree in a technical discipline or 2 year associates degree with 1 to 2 years pharmaceutical packaging experience or an equivalent training and/or experience. Experience in inspection of pharmaceutical or related industry is desired.
- Good documentation and communication skills
- Good organizational and planning skills
LANGUAGE SKILLS:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
MATHEMATICAL SKILLS:
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
LANGUAGE SKILLS:
Ability to respond to common inquiries or complaints from customers, supervisors or peers. Ability to effectively communicate with the following groups:
- Internal: Frequent contact with Quality Department, and Operations Department employees for information on quality inspection issues and cGMP issues.
- External: Occasional contact with customer representatives related to quality inspections
REASONING ABILITY:
Ongoing contact with internal Operations and Quality Department employees. Good mental skills for analysis and problem solving are needed.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; sit; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.
Under the direction of a Manufacturing Supervisor, directs employees' activities within an assigned manufacturing room or areas to package pharmaceuticals. Leads the assigned packaging associates to run validated processes to achieve established production schedules. Takes complete responsibility for the product quality, resource utilization, operational efficiency and employee safety within the assigned packaging room. Assist supervisor to ensure that all processes utilized and products packaged conform to customer and Company standards and specifications.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following: will be assigned to a line/area as a production person; (usually the supply person). Other duties may be assigned.
Communicates supervisor's job orders to employees.
Get machines started efficiently.
Call a mechanic when the machine is down.
Recheck components brought onto the line by the material handler against the batch record.
Call a material handler to restock the line.
Check quality, lot number and expiration date while the job is running.
Ensure 200 % inspection forms are completed, as required.
Ensure all batch record entries, including daily room checks are performed.
Assist with lot changes by counting components for accurate accountability.
Calculates and records counts as required.
Maintain line/area in an orderly and safe manner while maintaining GMPs.
Notify supervisor with personnel issues.
Reports downtime on appropriate form.
Observe packaging operations for optimum performance.
Recommend measures to improve production methods, equipment performance, and quality of product.
Assist supervision with reporting the production performance metrics.
Suggest changes in working conditions and use of equipment to increase efficiency of work crew.
Responsible for training the designated peers as a replacement. This is completed at management's request.
SUPERVISORY RESPONSIBILITIES:
Responsible for notifying production supervisors of performance, policy and personnel issues, but not accountable for enforcement of policy.
QUALIFICATIONS:
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Must be reliable and have an excellent attendance record.
EDUCATION and/or EXPERIENCE:
Preferred 4 year BS, BA or BT degree in a technical discipline or 2 year associates degree with 1 to 2 years pharmaceutical packaging experience or an equivalent training and/or experience. Experience in inspection of pharmaceutical or related industry is desired.
- Good documentation and communication skills
- Good organizational and planning skills
LANGUAGE SKILLS:
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
MATHEMATICAL SKILLS:
Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.
LANGUAGE SKILLS:
Ability to respond to common inquiries or complaints from customers, supervisors or peers. Ability to effectively communicate with the following groups:
- Internal: Frequent contact with Quality Department, and Operations Department employees for information on quality inspection issues and cGMP issues.
- External: Occasional contact with customer representatives related to quality inspections
REASONING ABILITY:
Ongoing contact with internal Operations and Quality Department employees. Good mental skills for analysis and problem solving are needed.
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
PHYSICAL DEMANDS:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to talk or hear. The employee frequently is required to stand; walk; sit; use hands to finger, handle, or feel; and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, and ability to adjust focus.
WORK ENVIRONMENT:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to moving mechanical parts. The noise level in the work environment is usually moderate.