Formulation Technician II
Bend, Oregon
Employer: Chipton Ross
Industry: MAN
Salary: Competitive
Job type: Full-Time
Chipton-Ross is seeking a Formulation Technician II for a contract opportunity in Bend, OR.
SUMMARY:
Performs current Good Manufacturing Practices (cGMP) production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms (tablets, capsules, granules). Executes process documentation in a fast-paced manufacturing environment.
RESPONSIBILITIES:
1. Maintains cleanliness of work areas and facility with assistance of assigned personnel.
2. Prepares manufacturing suites and components for Production Batch Record execution.
3. Can sign as a verifier on logbooks and other forms.
4. Executes Production Batch Records (PBRs). Executes Work Orders (WOs).
5. Ability to work independently and have experience to be a verifier on at least one line of unit operations.
6. Keeps proper Personal Protective Equipment (PPE) and gowning materials supplied in gowning suite.
7. Maintains cGMP materials inventory according to applicable Standard Operating Procedures (SOP's).
8. Revises SOPs and generates new SOPs when required.
9. Performs equipment qualification.
10. Cleans and visually inspects the processing equipment, tools, and utensils for cleanliness per the appropriate SOP and documents those activities.
11. Ensures that all cGMP equipment and parts are properly labeled.
12. Performs other technician responsibilities as necessary.
REQUIRED EXPERIENCE:
Minimum of one (1) year of production experience in the pharmaceutical industry required.
Good knowledge of current Good Manufacturing Practices (cGMP) and experience with cGMP documentation, spreadsheets and software applications preferred. Pharma or biotech experience highly preferred. Proven track record of producing an excellent work product with a high degree of accuracy. Ability to multi-task and handle shifting priorities in a fast-paced manufacturing environment. Strong proficiency in Microsoft Office Suite (Word and Excel). Effective written and interpersonal skills.
PHYSICAL REQUIREMENTS:
Work setting: Production of pharmaceutical dosage forms in a small-scale manufacturing suite setting. Position requires frequent standing (up to 8 hours) as well as ordinary ambulatory skills and physical coordination sufficient to move about office, laboratory & manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium to heavy weights of 35-50 pounds; arm, hand and finger dexterity, including ability to grasp and move for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate laboratory equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
EDUCATION:
Accredited High School Diploma or GED
Associate's degree and/or military experience preferred
WORK HOURS:
Full-Time 6:00 AM - 3:00 PM M-F, OT possible, however, not likely.
SUMMARY:
Performs current Good Manufacturing Practices (cGMP) production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms (tablets, capsules, granules). Executes process documentation in a fast-paced manufacturing environment.
RESPONSIBILITIES:
1. Maintains cleanliness of work areas and facility with assistance of assigned personnel.
2. Prepares manufacturing suites and components for Production Batch Record execution.
3. Can sign as a verifier on logbooks and other forms.
4. Executes Production Batch Records (PBRs). Executes Work Orders (WOs).
5. Ability to work independently and have experience to be a verifier on at least one line of unit operations.
6. Keeps proper Personal Protective Equipment (PPE) and gowning materials supplied in gowning suite.
7. Maintains cGMP materials inventory according to applicable Standard Operating Procedures (SOP's).
8. Revises SOPs and generates new SOPs when required.
9. Performs equipment qualification.
10. Cleans and visually inspects the processing equipment, tools, and utensils for cleanliness per the appropriate SOP and documents those activities.
11. Ensures that all cGMP equipment and parts are properly labeled.
12. Performs other technician responsibilities as necessary.
REQUIRED EXPERIENCE:
Minimum of one (1) year of production experience in the pharmaceutical industry required.
Good knowledge of current Good Manufacturing Practices (cGMP) and experience with cGMP documentation, spreadsheets and software applications preferred. Pharma or biotech experience highly preferred. Proven track record of producing an excellent work product with a high degree of accuracy. Ability to multi-task and handle shifting priorities in a fast-paced manufacturing environment. Strong proficiency in Microsoft Office Suite (Word and Excel). Effective written and interpersonal skills.
PHYSICAL REQUIREMENTS:
Work setting: Production of pharmaceutical dosage forms in a small-scale manufacturing suite setting. Position requires frequent standing (up to 8 hours) as well as ordinary ambulatory skills and physical coordination sufficient to move about office, laboratory & manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of medium to heavy weights of 35-50 pounds; arm, hand and finger dexterity, including ability to grasp and move for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate laboratory equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
EDUCATION:
Accredited High School Diploma or GED
Associate's degree and/or military experience preferred
WORK HOURS:
Full-Time 6:00 AM - 3:00 PM M-F, OT possible, however, not likely.
Created: 2024-06-29
Reference: 211637
Country: United States
State: Oregon
City: Bend
ZIP: 97702