Associate I/II, Quality Systems (South San Francisco)

Quality Systems Associate I/II needed to support the Quality Systems group in a biopharmaceutical company. The position is responsible for oversight of the Corrective and Preventive Action and Deviation programs. The candidate should have a good understanding of cGMP requirements. The position requires an individual who can work well independently as well as in a team environment. The position also requires a high degree of accuracy and attention to detail.

Primary Responsibilities

• Responsible for oversight of the Corrective and Preventive Action (CAPA) and Deviation programs.
• Maintain and update CAPA and Deviation databases.
• Maintain and organize hard copy files for all CAPA and Deviation documents on-site assuring traceability.
• Assist investigations of Deviations
• Lead the effort in documenting the initiation and closure and assist in the development of CAPA arising from Regulatory Inspections.
• Monitor CAPA and Deviation commitments to assure timely closure of activities.
• Provide, on a periodic basis, summary status reports of CAPA and Deviation activity to operations and in support of Annual Product Review and Management Review.
• Participate in program and database improvements.
• Assist with the development of the training curriculum and provide intra- and inter-departmental GMP training.
• Identify and implement improvements to procedures and forms.
• Provides support during audits and regulatory inspections.
• Provides operational support for other QA functions.

Additional Skills

• Knowledge and experience in cGMP, preferably in a commercial biopharmaceutical organization.
• Excellent organization and documentation skills.
• Detail oriented.
• Computer skills, including Microsoft Word, Excel, and Access

• BA or BS in a scientific discipline with 5-8 years of industry experience, 3-5 years in Quality Systems or Quality Assurance departments working directly with CAPA and Deviations or other Quality System Elements such as Change Control, Document Control, or Supplier Quality, in a commercial cGMP environment, preferably in a pharmaceutical/ biotechnology/medical device company.

To Apply:
Please reference the position of interest with your resume & cover letter
E-MAIL: recruit@solsticeneuro.com  FAX: (267) 620-8190

We provide a competitive compensation and benefits package, including 401K and stock options. We are proud to be an Equal Opportunity Employer. M/F/D/V