Work Schedule
Second Shift (Afternoons)
Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Standing for full shift
Job Description
Summary:
Performs current Good Manufacturing Practices (cGMP) production of pharmaceutical Spray Dried Intermediates (SDI) and Solid Dosage Forms (tablets, capsules, granules). Completes process documentation in a fast-paced, flexible manufacturing environment.
Crucial Functions:
1. Maintains cleanliness required of equipment, work areas, and facility.
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2. Prepares manufacturing suites and components for Production Batch Record execution.
3. Completes Production Batch Records to make pharmaceutical products.
4. Verifies baseline GMP activities.
5. Operates in a safe manner, wears appropriate PPE, and identifies and raises any safety hazards.
6. Follows established waste disposal operations.
7. Evaluates processes for continuous improvement.
8. Performs tasks of growing complexity with a higher degree of independence.
9. Performs all duties in a cGMP manner.
10. Follows all appropriate SOPs, Good Documentation Practices, and Data Integrity procedures.
11. Exhibits the 4i Values (Integrity, Intensity, Innovation, and Involvement).
12. Performs other technician responsibilities as vital.
Education:
HS Diploma or equivalent required.
Experience:
1+ year of work experience in manufacturing/production environment; pharma preferred.
Equivalency:
Equivalent combination of education, training, and meaningful work experience may be considered.
Proficiencies:
Good knowledge cGMPs and experience with cGMP documentation, spreadsheets and software applications preferred. Pharma or biotech experience highly preferred. Proven record of producing an excellent work product with a high degree of accuracy. Good work ethic, mechanical aptitude, and a desire to learn. Ability to multi-task and handle shifting priorities in a fast-paced, highly regulated manufacturing environment. Effective written and interpersonal skills. Attention to detail and the ability to follow written and verbal instructions.
Physical Requirements:
Work setting: Production of pharmaceutical dosage forms in a small-scale manufacturing facility. 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.
Disclaimer:
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as a comprehensive statement of work, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to build an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully align with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Please take note that we require a negative drug screen, coordinated by our third-party vendor, as a condition of employment.