DURECT's compensation package includes a competitive salary, stock options, comprehensive benefits package, along with a dynamic corporate culture and supportive team environment.
Job Title: QA Specialist II/III
Location: Vacaville, CA
Description:
Main Purpose of Position: Provide QA support for commercial manufacturing by performing a wide variety of activities to ensure compliance with DURECTs's SOPs, current Good Manufacturing Practices (cGMPs) and other applicable regulations. Activities to include sampling and inspection for GMP incoming components, line clearance and in-process inspection for GMP manufacturing, and batch record review. Main Duties and Responsibilities: - Inspection and sampling of incoming components and packaging materials.
- Performance of line clearance and in-process inspection of GMP manufacturing.
- Batch record review.
- Review GMP incoming component records.
- Initiate troubleshooting activities, corrective and preventive actions plans, and follow up activities associated with manufacturing or quality control deviations and non-conforming materials.
- Participate in audits to ensure compliance with cGMPs and approved procedures.
- Perform trend analysis of data generated.
- Assist in the resolution of company product complaints.
- Perform sampling for environmental monitoring of production facility.
- Identify and initiate quality improvements in systems and procedures as needed.
Requirements:
- BA/BS degree in scientific discipline or equivalent.
- Knowledge of applicable regulatory requirements such as CFR 21 Parts 210, 211.
- 2-5 years of Quality Assurance experience in an FDA regulated manufacturing environment with similar responsibilities.
- Experience with commercial manufacturing operations highly preferred.
- Maintains a high level of commitment to quality of work.
- Excellent writing, verbal and interpersonal communication skills.
- Able to remain focused in a constantly changing environment.
- Attention to detail critical.
- Proficient computer skills.
Working Conditions: - Work is normally performed in a typical office work environment / some warehouse work is needed.
- Light physical effort. Requires handling of average weighted object up to 10 pounds or some standing or walking.
IMPORTANT: In the subject line of your email please include your SURNAME, FIRSTNAME, followed by 542Feb08_1VACJJ (copy and paste). Your submission MUST contain this exact job-number, NOT THE JOB TITLE, in order to be properly routed and considered. DURECT Corporation is an Equal Opportunity Employer
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