QA Associate I, Process Quality Inspector
Verona, WI 
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Posted 8 days ago
Job Description
Our Company:

Coating Place, Inc. has been in the contract manufacturing industry for over 40 years. Our continued goal to provide the highest quality Wurster processing has kept us at the forefront of the “fluid bed micro-encapsulation” market. Our company mission helps us to maintain this focus.

“Coating Place is an established pharmaceutical contract manufacturer specializing in Wurster fluid bed processing and delivery system development. We provide our customers with modified and extended release bulk active products through innovative development and manufacturing capabilities with an integrated quality philosophy.”
It is our mission to continue urging the next generation, candidates like you, into these fields and further expand the capabilities of the industry through their capabilities. 

Coating Place is a stable and growing company that offers a friendly work environment and an incredibly competitive benefits package including: health, dental, and vision insurance, a generous paid time off program to help balance work and personal life, and pre-tax 401(k) and after-tax Roth 401(k) contribution options with the company matching up to 5% of gross wages that is 100% vested at the time it is added to the employee’s account. In addition, Coating Place may choose to make a profit sharing contribution to your account!


Position Overview:

The QA Associate I, Process Quality Inspector provides quality assurance support and leadership to the Production Department. The QA Associate I, Process Quality Inspector provides a strong floor presence and works directly with production supervision and operators to maintain quality of manufacturing operations. 


Essential Job Functions:
  • Works with Production personnel to ensure compliance of CPI practices, policies, and procedures.  A significant focus on batch record and process compliance is expected.  Performs routine review of in process production documents during processing to ensure accuracy and completeness.
  • Performs routine inspections/audits on personnel, procedures, equipment, and products.
  • Provides leadership to Production personnel on quality issues.
  • Initiates deviations and documents initial investigations.  May contribute to assessment of deviations under the direction of the supervisor.
  • Contributes to quality investigations.  Serves as lead investigator when assigned by the supervisor.
  • Initiates, maintains, and dispositions non-conformances.
  • Assists in training of Production personnel in company practices, policies, and procedures.
  • Assists in the movement of controlled substances into/out of the controlled substance storage and processing areas.
  • Performs sampling activities when assigned by the supervisor.
  • Reviews unit logbooks and/or environmental monitoring data as assigned.
  • Follows all CPI cGMP practices, policies, and procedures.
  • Follows all CPI safety practices, policies, and procedures.
  • Other duties as assigned.
Education/Skills/Knowledge Required:
  • High school diploma or equivalent required.
  • 2-3 years of industry quality or cGMP manufacturing experience required. Formal quality training may be substituted in place of experience.
  • Knowledge of current Good Manufacturing Practices (cGMPs) preferred.
  • Knowledge of a variety of cGMP manufacturing practices preferred (including fluid bed coating/granulation, capsule filling, milling, tableting)
  • Strong attention to detail and problem solving skills required.
  • Ability to read, write (legibly), and speak the English language at a level necessary for efficient job performance.
  • Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients.
  • Ability to stand for extended periods of time and lift objects weighing up to 55 lbs.

 

Job Summary
Start Date
ASAP
Employment Term and Type
Regular, Full Time
Hours per Week
40
Work Hours (i.e. shift)
2nd Shift
Salary and Benefits
Based on Experience
Sign On Bonus- 50% paid out after formal completion of initial training, 50% paid out after 1st year of service.
Required Education
High School or Equivalent
Required Experience
2+ years
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