Responsible for the mechanical setup, operation, control, monitoring and cleaning of various manufacturing equipment to produce soft gel, solid dosage, semi-solid and/or liquid dosage forms following Standard Operating Procedures (SOPs).
DUTIES & 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.
- Ensures work area is neat, clean and orderly by end of shift.
- Practices good housekeeping skills utilizing 5S techniques
KNOWLEDGE, SKILLS, EXPERIENCE:
- 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
- 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.
Pharmaceutics International, Inc. (“Pii") is proud to be an Equal Opportunity Employer, including supporting applicants and employees with a disability or protected veterans, as well as any other status protected by law.
Pharmaceutics International Inc