Quality Control Cleanroom Inspector
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Type: Contract to Hire
Location: Livonia, MI
Description
Job Duties & Responsibilities
• 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 throughout 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:
o a) Floors, walls, and ceilings of smooth, hard surfaces that are easily cleanable; report any
observation to the production and quality department.
o b) Temperature and humidity controls are as appropriate.
• Review Formula Card for proper Verification of startup products vs. WO
• Water resistivity before starting the washing procedure.
• TOC testing of water.
• Cleanliness Check of Perforated Stainless Steel cleaning Baskets, Cover baskets, Cover trays, and
Cookie trays.
• Clearance of Loading Area Check, Loading Table and surrounding to be Free of products and
Clean.
• Drying / Depyrogenation- Oven Cycle Temperature Ticket Check.
• Clearance of Intimate packaging process:
o a) items vs. MO/WO (Spacer, Bag size, bracket, vials, etc.) And
o b) cleanliness check of the Parts such as Cover Baskets, Tweezers, a special tool (check
instruction)
o c) Table Clean and Clear of previous WO
• Perform inspection of any Quantity sufficient (QS) for Vials or missing items.
• Checks Sealers Temperature setting.
• Checks Autoclave Cleanliness and clearance.
• Ensures the Verification of information 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 deviation.
• Reports on any Non-conformances.
• Handles the workflow of any Rework or Reprocessing work.
• Verifies the double-bagging area and products on the line.
Qualifications
• 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.
• B.S in Physical Science.
• Requires attention to detail.
• Good problem-solving skills.
• 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, Access)
EEOC
Synergy Solutions is an equal opportunity employer. In keeping with the values of Synergy, we make all
employment decisions without regard to race, religion, color, sex, age, national origin, ancestry, sexual
orientation, physical handicap, mental disability, medical condition, disability, gender or identity or
expression, pregnancy or pregnancy-related condition, marital status, height and/or weight. The list of duties
and responsibilities outlined above is representative and may not be a complete and detailed list of tasks.
Employees must perform any and all other duties assigned by his or her supervisor. Additionally, this job
description does not constitute a contract of employment