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Standard (MonFri)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 shiftJob Description
Work Shift: MondayThursday 2pm1am
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 fastpaced 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 .
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 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 multitask and handle shifting priorities in a fastpaced 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 smallscale 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 3550 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.
Required Experience:
Senior IC
Full-Time