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Quality Auditor
Verona, WI
Job Description
OUR COMPANY:
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: 100% company paid health and dental insurance premiums for our employees and their dependents, 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 Quality Auditor is responsible for administrative activities of the electronic documentation system, system validation documentation, coordinating and performing internal QA audits, supply chain activities and performing external audits, and review of controlled documentation. Coating Place, Inc. has been in the contract manufacturing industry for the last 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: 100% company paid health and dental insurance premiums for our employees and their dependents, 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:
ESSENTIAL JOB FUNCTIONS:
- Perform routine document change control and maintenance activities (e.g., SOPS and controlled forms) using the electronic document management system.
- Coordinate document control including effective document review and approval flow to ensure smooth revision cycle.
- Coordinate and perform internal QA audits to ensure compliance with existing SOPs and regulations.
- Perform external vendor qualification audits and report findings, as required.
- Perform data review activities for QC data, Engineering & Maintenance, etc.
- Assist with any departmental initiatives and projects, as assigned by QA management.
- Implementation and management of an electronic document management system.
- Participate in supply chain qualification activities.
- Support and complete documentation required for any changes/improvements per functional/departmental requirements (change control, procedure updates, etc.).
- Analyze existing documentation to ensure it is updated, reviewed, and maintained as appropriate.
- Participate in investigations, as directed.
- Promote continuous process improvement for more efficient, successful document and information control.
- Adhere to appropriate quality and validation standards, including SOPs and make recommendations on system documentation.
- Coordinate individual and company training programs, as required.
- May lead or direct the work of others.
- Follows all CPI cGMP and safety practices, policies, and procedures.
- Other duties as assigned.
EDUCATION/SKILLS/KNOWLEDGE REQUIRED:
- Bachelor's Degree in a Science or Quality related field, preferred.
- 3-5 years previous pharmaceutical or food experience supporting manufacturing operations including batch record review, document change control, quality systems, and validation.
- Experience with electronic document management systems, a plus.
- Experience performing quality audits or certification, a plus.
- Experience in Supply Chain Qualification, a plus.
- Demonstrated knowledge of cGMPs, FDA, and other regulatory agency requirements.
- Demonstrated technical knowledge and understanding of facilities, equipment, and quality systems within a pharmaceutical setting.
- Proficiency in Microsoft Office (Word and Excel), SharePoint preferred.
- Ability to communicate both verbally and in writing across all levels of the organization, internally and externally.
- Ability to translate process knowledge into concise, traceable, reproducible, and accurate instructions.
- Ability to multi-task and work in a deadline-driven environment.
- Strong working knowledge of editing, proofreading, spelling, grammar, and punctuation.
- Excellent organizational and multi-tasking skills.
- Sound practical judgment of priorities and high attention to detail.
- A continuous improvement and quality mindset.
- Ability to establish and maintain effective working relationships with team members, co-workers, and/or clients.
Job Summary
Start Date
As Soon As Possible
Employment Term and Type
Regular, Full Time
Hours per Week
40
Work Hours (i.e. shift)
1st Shift
Salary and Benefits
Based On Experience
Required Education
Bachelor's Degree
Required Experience
3+ years
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