Manufacturing Technician B - Soft Gel
BASIC FUNCTION:
Responsible for the mechanical setup, operation, control, monitoring and cleaning of various manufacturing equipment to produce solid dosage, semi-solid and liquid dosage forms following Standard Operating Procedures (SOPs).
RESPONSIBILITIES:
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Performs assigned duties as outlined in the SOPs for manufacture of pharmaceutical products according to written instructions from Product Batch Records with assistance from Manufacturing Technicians.
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Performs setups, operation, disassembly and monitoring of processing equipment per specifications or batch formula instructions for solid, semi-solid and liquid dosage forms.
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Performs cleaning procedures on processing equipment and manufacturing areas using written procedures, cleaning solutions and materials.
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Notifies Management of any observed current Good Manufacturing Practices (cGMP) violations encountered during the performance of job duties and responsibilities.
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Completes appropriate paperwork necessary for drug manufacturing and to comply with Code of Federal Regulations (CFR) Parts 210-211.
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Provides assistance to management in the revision and/or writing of SOPs to assure accuracy and completeness in conducting the manufacturing process.
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Follows all safety procedures within the cGMP manufacturing areas and reports all discrepancies to management immediately.
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nsures work area is neat, clean and orderly by end of shift.
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Practices good housekeeping skills utilizing 5S techniques
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ditional functions and responsibilities as needed or assigned.
REQUIREMENTS:
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Ability to read, write, and speak English fluently.
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Proficient in the operation of manufacturing equipment and processes; knows and complies with Material Safety Data Sheets (MSDS), SOP requirements, and trained in cGMPs.
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Must be familiar with metric system, weight and volume measurements and capable of basic conversions
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To perform the job successfully, an individual should demonstrate the following competencies:
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Identifies and resolves problems in a timely manner
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Mechanically inclined; reads and interprets equipment and process documents; follows operating instructions; and good computer skills.
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Exhibits objectivity and openness to others’ view. Takes personal accountability for contributions to team and organizational results.
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Shows respect and sensitivity for personal and cultural differences. Values multiple viewpoints and is sensitive to factors (race, gender, age, culture, and religion) that may affect behavior and feelings.
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Works with integrity and ethically; maintains confidentiality
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Treats others with respect and consideration.
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Is consistently at work and on time.
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Follows instructions, responds to management direction; takes responsibility for own actions.
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Demonstrates accuracy and thoroughness; looks for ways to improve and promote quality. Consistently checks all documents for errors and constantly strives for right the first time mentality.
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Observes safety and security procedures; responsible for meeting department safety objectives and to develop on-going safe operating procedures consistent with the job requirements.
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QUALIFICATIONS:
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HS/GED required with a minimum of 6 months experience as a Manufacturing Technician Trainee within Pii or a minimum of 2 years in the pharmaceutical, cosmetic, or food industry.
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Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals and percents.
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Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
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Basic computer skills, i.e, Outlook. Microsoft Word