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:

• 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.

• Performs setups, operation, disassembly and monitoring of processing equipment per specifications or batch formula instructions for solid, semi-solid and liquid dosage forms.

• Performs cleaning procedures on processing equipment and manufacturing areas using written procedures, cleaning solutions and materials.

• Notifies Management of any observed current Good Manufacturing Practices (cGMP) violations encountered during the performance of job duties and responsibilities.

• Completes appropriate paperwork necessary for drug manufacturing and to comply with Code of Federal Regulations (CFR) Parts 210-211.

• Provides assistance to management in the revision and/or writing of SOPs to assure accuracy and completeness in conducting the manufacturing process.

• Follows all safety procedures within the cGMP manufacturing areas and reports all discrepancies to management immediately.

• nsures work area is neat, clean and orderly by end of shift.

• Practices good housekeeping skills utilizing 5S techniques

• ditional functions and responsibilities as needed or assigned.​

REQUIREMENTS:

• Ability to read, write, and speak English fluently.

• Proficient in the operation of manufacturing equipment and processes; knows and complies with Material Safety Data Sheets (MSDS), SOP requirements, and trained in cGMPs.

• Must be familiar with metric system, weight and volume measurements and capable of basic conversions

• To perform the job successfully, an individual should demonstrate the following competencies:

  • Identifies and resolves problems in a timely manner

  • Mechanically inclined; reads and interprets equipment and process documents; follows operating instructions; and good computer skills.

  • Exhibits objectivity and openness to others’ view. Takes personal accountability for contributions to team and organizational results.   

  • 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.

  • Works with integrity and ethically; maintains confidentiality

  • Treats others with respect and consideration.

  • Is consistently at work and on time.

  • Follows instructions, responds to management direction; takes responsibility for own actions.

  • 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.

  • Observes safety and security procedures; responsible for meeting department safety objectives and to develop on-going safe operating procedures consistent with the job requirements.

QUALIFICATIONS:

• 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.

• Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals and percents.

• Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.

• Basic computer skills, i.e, Outlook. Microsoft Word