Work Schedule

Standard (Mon-Fri)

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, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), 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).  Manages process documentation in a fast-paced, flexible manufacturing environment.

Crucial Functions: 

1. Progresses towards Subject Matter Expertise on a single process train.

2. Verifies GMP activities.

3. Achieves Qualified Trainer status.

4. Maintains cleanliness required of equipment, work areas, and facility; performs visual equipment inspections.

5. Prepares manufacturing suites and components for Production Batch Record execution.

6. Executes Production Batch Records to make pharmaceutical products.

7. Operates in a safe manner, wears appropriate PPE, and identifies and raises any safety hazards.

8. Follows established waste disposal operations.

9. Leads continuous improvement activities.

10. Performs tasks of growing complexity with a higher degree of independence.

11. Mentors new team members.

12. Updates quality documents.

13. Assists in the execution of equipment qualification activities and maintenance, including liaison for third party vendors.

14. Performs all duties in a cGMP manner.

15. Follows all appropriate SOPs, Good Documentation Practices, and Data Integrity procedures.

16. Exhibits the 4i Values (Integrity, Intensity, Innovation, and Involvement).

17. Performs other responsibilities as vital.

Education:

HS Diploma or equivalent required.

Experience:

3+ 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 of current Good Manufacturing Practices (cGMP) and experience with cGMP documentation, spreadsheets and software applications preferred.  Pharma or biotech experience highly preferred.  Consistent 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 social skills. Attention to detail and the ability to follow written and verbal instructions. Proficiency in Microsoft Office Suite (Word and Excel).

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.