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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: (California) Quality Assurance Specialist II
Location: Cupertino, CA
Description:
MAIN PURPOSE OF POSITION:
Perform a wide variety of activities to ensure compliance with applicable DEA /GMP/GLP regulatory requirements by maintaining controlled substance inventory and transfer records, reviewing manufacturing and quality control documentation, conducting audits and assisting with training programs. Conduct investigations related to manufactured products and generate written reports.
MAIN DUTIES AND RESPONSIBILITIES:
· Maintain controlled substance inventory and transfer records .
· Review manufacturing batch records.
· Review quality control test results.
· Perform sampling, labeling and inspection of incoming raw materials.
· Identify and initiate quality improvements in systems and procedures as needed.
· Initiate troubleshooting activities, corrective and preventive actions plans, and follow up activities associated with manufacturing or quality control deviations and non-conforming materials.
· Assist in the resolution of company product complaints.
· Perform audits to ensure compliance with DEA, cGMPs, and GLPs regulations and DURECT procedures.
· Perform trend analysis of data generated.
· Generate QA related documentation as required for filing with regulatory bodies.
Requirements:
Knowledge/Education
· BA/BS degree in scientific discipline or equivalent.
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Job Experience
· 2-5 years of experience in an FDA regulated manufacturing environment with similar responsibilities.
· Experience with Controlled Substances
Skills/Competencies
· Maintains a high level of commitment to quality of work.
· Able to remain focused in a constantly changing environment.
· Attention to detail critical.
Essential Job Functions
· Ability to walk, climb, stand, bend (neck and/or waist), kneel, reach, stoop, squat, twist (neck and/or waist), push, pull, and use of both hands for extended periods of time while performing tasks
· Ability to lift, move and handle materials weighing up to 25 lbs unassisted
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WORKING CONDITIONS:
· Work is normally performed in a typical office work environment / some warehouse and laboratory work is required
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