This position is responsible for aspects of process, equipment, facility and computer validation support, ownership of key quality systems supporting daily operations, performance of mandatory quality record review and approvals, and independent continuous improvement projects.
Duties and Responsibilities / Essential Functions:
- Utilizes standard statistical analysis techniques to evaluate process capability; provides technical guidance and training to other team members in statistical analysis techniques, experimental design, data analysis, sampling techniques and other traditional QA Engineering activities
- Participates in site validation and equipment qualification programs; routinely involved with generation, review and/or approval of IQ, OQ, PQ protocols and reports
- Supports the CAPA program by working directly with all departments to ensure timely root cause identification for process/product deviations; may organize, facilitate and document Material Review Board activities
- Supports quality and operations staff by ensuring effective corrective and preventive actions are identified and implemented
- Participates in internal audit programs
- Monitors incoming raw material quality and works with suppliers to improve quality of both delivered products/services and internal quality processes
- Works with Quality and Operations management on short- and long-term quality planning and quality system improvements initiatives
- Actively participates in site-wide continuous improvement activities
- Drafting new, and revising existing Standard Operating Procedures (SOP)
- Prefer BS/BA Degree in Quality Engineering or a related a scientific/technical field (Biology/Chemistry/Engineering)
- ASQ CQE certification preferred
- Six Sigma and or Lean experience or certification preferred
- 2-5 years related experience, working in a regulated environment - working with Pharma or Medical Devices preferred
- Experience with Quality Inspection technique
- Experience conducting independent investigations – includes identification of CAPA
- Experience with Supplier Qualification and Monitoring
- Experience with Internal Auditing
- Demonstrated ability to work effectively and positively with all levels of an organization.
- Strong written and oral communication skills required
- Capable of working both independently and in a team setting; team oriented and committed to continuous improvement
- Proficient skills with Microsoft Office (Word, Excel, PowerPoint)
- Strong organization skills required
- Onward Search is an equal opportunity employer, dedicated to a policy of non-discrimination in an employment with regard to race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, veteran status or any other classification protected by federal, state and local laws and ordinances. Candidates must be at least 18 years old to be considered for employment. EOE/M/F/D/V/SO.
- In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
- The client is unable to support 1099 / Corp-to-Corp or Independent Contractor arrangements at this time. All freelancers will be paid as W2 employees.
- Onward Search is a drug-free workplace.
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