Manufacturing Production Operator

Job Description

Job Description

**SUPERVISORY RESPONSIBILITIES

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• No supervisory responsibilities.

**Essential Duties and Responsibilities

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• At the beginning of each shift, the employee receives instructions from the mfg. manager/supervisor, collects the required batch record information and follows the instructions in the batch record to manufacture a product.

• Ensures cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s).

• Must be in compliance at all times by following batch records, SOPs and all company policies

• Perform all in-process testing and inspections as required by the Master Batch Record

• Completes and signs the batch record where appropriate.

• Reports to the supervisor any issues that may arise during the manufacturing process.

• Upon completion of the batch, supervisor is notified and a new batch is assigned.

• Ensures proper execution of Master Batch Records’ Standard Operating Procedures.

• Ensures accurate completion of equipment logs, line clearance and/or lab notebooks.

• Ensures cleanliness and proper assembly of manufacturing equipment per approved procedures (SOP’s).

• Weighs out material

  and components

  for production batches.

• Identify and report quality issues.

• Must be in compliance at all times by following batch records, SOPs and all company policies.

• Report accidents and unsafe conditions or unusual circumstances to mfg. manager/ supervisor.

• Understands and adheres to all cGMP and FDA regulations.

• Responsible for maintaining a neat and orderly work area at all times.

• Cleaning and sanitization of manufacturing rooms including walls, floors, and ceilings per current SOPs

• Responsible for the set-up, operation and cleaning of manufacturing equipment and manufacturing suites.

• Ability to work both independently and with others.

**additional Job Responsibilities

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• Other duties may be assigned occasionally, as needed, by management

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**QUALIFICATIONS

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• Ability to read, comprehend and apply comprehensive knowledge of pharmaceutical cGMPs, SOP’s, Batch Records and training documents to ensure ongoing quality compliance.

• Ability to perform all requirements independently with limited managerial oversight.

• Superior attention to detail to ensure accuracy of work product.

• In accordance with FDA regulations, Production Operator must be free from illness that could jeopardize the safety or quality of products Such illness may include but are not limited to any contagious illness, condition that cause bleeding, open lesions, flaking or peeling skin

• Must be able to wear all types of required protective equipment.

**Education and/or Experience

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• Has a high school diploma or the equivalent.

• A minimum of one year QA experience and knowledge of FDA and cGMPs regulations is preferred.

**LANGUAGE SKILLS

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• Must be able to read, understand and clearly communicate in the English language.

• Ability to effectively present information and respond to questions from other departments.

• Excellent verbal and written communication skills are required to execute documents and interact successfully with other departments

**MATHEMATICAL SKILLS

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Ability to accurately perform mathematical calculations, including:

• Addition, subtraction, multiplication and division.

• Averages, percentages and fractions.

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**REASONING ABILITY

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• Ability to identify problems early on and quickly determine the most effective solutions.

• Skilled at knowing the right questions to ask in order to fully understand a problem or situation.

• Thinks in a logical manner with an emphasis on delivering the highest levels of internal and external services.

• A minimum of one (1) year QA experience and knowledge of FDA and cGMPs regulations is preferred.

• Ability to work on first and/or second shift, as well as overtime when required, and able to perform the physical tasks associated with sampling and inspecting.

• Must be a highly organized, reliable, detail-oriented, self-starter, able to multi-task and prioritize effectively.

• Excellent verbal and written communication skills are required to execute documents and interact successfully with other departments.

**INTERPERSONAL SKILLS/EMOTIONAL COMPETENCIES

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• Takes full responsibility for the quality of their work product.

• Employee must demonstrate the ability to work in a team environment

  ¨NBSP;

• Consistently meets deadlines.

• Excellent listening & comprehension skills.

• Effectively collaborates and supports the objectives of other teams.

• Gives clear direction and instructions.

• Remains calm under pressure.

• Able to multi-task without losing focus.

• Ability to positively adapt to change.

• Maintains a professional appearance and projects a positive attitude.

• Able to interact with other departments necessary for the successful manufacturing/packaging of products.

**PHYSICAL DEMANDS

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The physical demands described in this job description 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 stand for 8 hours and use hands to finger, handle, or feel. The employee frequently is required to reach with hands and arms. The employee is required to stand, walk, bend and talk or hear. The employee must occasionally lift, push or pull up to 50 pounds. Specific vision abilities required by this job include close vision and ability to adjust focus.

**WORK ENVIRONMENT

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The work environment characteristics described in this job description 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.

The noise level in the work environment is usually moderate to loud

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