QUALITY CONTROL MATERIAL INSPECTOR

DEPARTMENT QUALITY

• Ensures Cleanroom B personnel have the proper training before executing any task.
• Ensures Cleanroom B area has adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, closures, labeling, in-process materials, or drug products, and to prevent contamination.
• Ensures cleanroom B process follows the proper flow of components, drug product containers, closures, labeling, in-process materials, and drug products through the building.
• Ensures the receipt, identification, storage, and withholding from use of components, drug product containers, closures, and labeling, pending the appropriate sampling, testing, or examination by the quality control unit before release for manufacturing or packaging.
• Ensures proper manufacturing and processing, Packaging and labeling operations; Quarantine storage before the release of drug products;
• Ensures all equipment in Cleanroom B is identified and has the required Calibration dates.
• Ensures Aseptic processing, which includes as appropriate:

a)Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable; report any observation to the production and quality department
b)Temperature and humidity controls are as appropriate.

• Review Formula Card for proper Verification of startup products vs. WO
• Water resistivity before star ng the washing procedure
• TOC testing of water
• Cleanliness Check of Perforated Stainless Steel cleaning Baskets, Cover baskets, Cover trays, and Cookie trays
• Drying / Depyrogenation- Oven Cycle Temperature Ticket Check
• Clearance of packaging process:

MAJOR RESPONSIBILITIES
a) items vs. MO/WO (Spacer, Bag size, bracket, vials, etc..)
b) cleanliness check of the Parts such as Cover Baskets, Tweezers, a special tool (check instruction)
c) Table Clean and Clear of previous WO
Perform inspection of any Quan ty sufficient (QS) for Vials or missing items.

• Checks Sealers Temperature se ng
• C hecks Autoclave Cleanliness and clearance
• Ensures the Verifica on of informa on on autoclave strips for each work order is filled in and completed.
• Checks Autoclave sterility sticker colors.
• Verifies Omega Meter temperature data
• Verifies correct labeling of the Items on the carts
• Performs Line clearance before double bagging
• Checks and verifies the actual yields and percentages of theoretical yield calculations after each appropriate phase of manufacturing, processing, packaging, or holding of the drug product.
• Reports any deviations
• Reports any Non-conformances
• Handles the workflow of any Rework or Reprocessing work.
• Verifies the double-bagging area and products on the line.

Be able to comprehend Acorn’s environment of fast production and the need for urgency in getting things done without compromising the quality of the product.

• Requires attention to detail
• Good problem-solving skills

QUALIFICATIONS

• Good oral and written communication skills
• Ability to lift up to 20 lbs. consistently
• Ability to work standing for long periods of time
• Able to use office machinery (printers, scanners, etc.)
• Microsoft Office suite (Excel, Word, Outlook, PowerPoint)

Job Type: Full-time

Pay: $25.00 per hour

Benefits:

• 401(k)
• Dental insurance
• Flexible schedule
• Health insurance
• Paid time off
• Vision insurance

Experience level:

• 2 years

Schedule:

• 8 hour shift
• Monday to Friday

Work setting:

• In-person

People with a criminal record are encouraged to apply

Shift availability:

• Night Shift (Preferred)
• Overnight Shift (Preferred)

Work Location: In person