This role is a QA Specialist II, under the QA Manufacturing and Facilities Support team. This specific role is required to perform QA review of manufacturing and engineering records & associated documents and QA review & approval of procedures and GMP deviations. This position requires a sound knowledge of quality assurance systems, methods and procedures. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.
Essential Duties and Job Functions:
- Performs a variety of activities to ensure compliance with applicable cGxP regulatory requirements
- Reviews routine manufacturing and engineering documentation including batch manufacturing records
- Assists in the completion of Manufacturing related customer complaint investigations
- Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents
- Identifies deviations from accepted practices, exercises judgement to evaluate impact and determines appropriate actions
- Review and approval of GMP Deviation investigations and CAPAs
- Identifies problems and generates alternatives and recommendations
- Completion of routine/non-routine to more complex projects/assignments
- Performs internal audits and walkthroughs on behalf of the QA department to ensure site compliance to GMP
- Participates in site Strategic, Technical and Operational Excellence projects on behalf of QA and represents the QA function at relevant cross-functional meetings
- Normally receives very little instruction on routine work, general instructions on new assignments
Knowledge, Experience and Skills:
- Prior experience in pharmaceutical industry is preferred (ideally within a QA role)
- Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
- Demonstrates working knowledge of quality assurance systems, methods and procedures.
- Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
- Demonstrates audit and investigation skills, and report writing skills.
- Good verbal, written, and interpersonal communication skills.
- Proficiency in Microsoft Office applications.
Typical Education & Experience:
- 4+ years of relevant experience in a GMP environment related field and a BS.
- 3 + years of relevant experience and a MS.
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As an Equal Opportunities employer we welcome applications from all suitably qualified persons regardless of their race, sex, disability, religion/belief, sexual orientation or age.