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2016-12-14 09:56:42
The QA Specialist
Key Skills:
QA Specialist - Quality Agreements LOC : Middleton, WI,
2016-12-14 09:56:42
Job Type:
Full Time only
Budget $: 100,000 - 200,000
Budget $: 100,000 - 200,000
The QA Specialist
- GMP must be knowledgeable of regulations, SOPs, QA departmental policies and procedures, and demonstrate proficiency with audit procedures and proper documentation, in addition to knowledge in his/her area of expertise.
- Additionally, the QA Specialist will be responsible for review, negotiation and tracking of client quality agreements and for providing clients with information required for regulatory submissions.
- Certified Quality Auditor (ASQ), registered RQAP-GLP (SQA) or certification/registration in another recognized and relevant organization.
- A college degree in chemistry or related science or an equivalent combination of education and experience.
- At least 5 years of QA experience is required. QC or senior scientist experience may be substituted for part of the QA experience.
- Or equivalent combination of education, training and experience that proved the individual with the required knowledge, skills, and abilities.
- Expertise in one or more specialized areas relevant to QA activities, e.g.
- Computer systems, root cause analysis, TQM.
- Knowledge of chromatography, immunochemistry or statistics is required.Good verbal and written communication skills are necessary.Must be detail oriented and able to set priorities.
- Minimal supervision is required.Interactions with supervisor are primarily to inform the supervisor of activities.
- Good interpersonal skills.Basic computer skills (Word Processing, Excel, etc.).
- Ability to handle multiple priorities, tight deadlines and changing priorities.
- Experience reviewing and tracking of Quality Agreements and facilitation of Client Audits.
- Addition to staff justified due to increasing volume of records and number of client audits.
- LLC is firmly committed to Equal Employment Opportunity (EEO) and prohibits employment discrimination for employees and applicants based on age, race, color, pregnancy, gender, gender identity, sexual orientation, national origin, religion, marital status, citizenship, disability or protected veteran or other status protected by federal, state, and/or local law.
Key Skills:
