job summary:
Immediate opportunity for a REMOTE Quality Assurance Specialist in Product Complaints with a leading biotechnology company located in Thousand Oaks, CA.
As a Specialist Quality Assurance - Product Complaints, you will support the product complaint system through triage of product complaints and management of Level I complaint processing and closure in adherence with Company Complaint policies and procedures, while assuring compliance to federal regulations.
Position Type: 1 year contract (through 12/31/25)
Schedule/Shift: Mon.-Fri., 8am-5pm, any time zone
Location: Newbury Park, California
Job Type: Contract
Salary: $35.00 - 39.84 per hour
Work Hours: 9 to 5
Education: Masters
responsibilities:

• Ensuring complaints are accurately entered into the complaints database in a timely manner, triaging complaints to determine complaint code and investigation level.
• Determining whether the complaint is associated with an adverse event or medical device, documentation of follow-up communication to complainants for additional information or complaint sample returns.
• Re-assigning complaints to the appropriate investigation site, closing complaints per required timeframes and providing responses to the complainant.
• Working with other Company departments, contract partners and call centers to resolve discrepancies/deficiencies.
• Prioritizing complaints and understanding the importance of accurate data entry of complaints within the required timeframe.
• Notifying appropriate parties upon receipt of complaints, supporting the complaints returns process by determining follow-up required for complaint return samples and documentation of communication attempts.
• Partnering with call centers providing tactical oversight and support, providing written communication to senior management and team members, and performing other duties as assigned by supervisor.

qualifications:

• Bachelor's (BS) degree required. Master's degree (MS) preferred.
• Five (5) years of biopharmaceutical experience responsibility in a quality, analytical development, process development, pharmaceutics, regulatory, or manufacturing environment.
• Understanding of biopharmaceutical bulk and drug product manufacturing and distribution processes.
• General knowledge of cGMP and filing regulations, practices, and trends pertaining to the manufacture, testing and distribution of biopharmaceuticals.
• Experience with quality management systems (QMS).
• Veeva knowledge and experience preferred.
• Self-motivated, able to interface effectively with various levels, and have careful attention to details.
• Able to prioritize and meet deadlines, possessing excellent leadership, problem solving, analytical, and customer service skills.
• Well-organized, possess excellent oral and written communication skills, focus on process improvements, and manage a large number of complex projects simultaneously.
• Ability to evaluate issues, make quality decisions and understand when to escalate, if necessary.

Competencies/Skills:

• Project management skills including detailed note taking, planning and scheduling meetings and/or workshops, presentation creation, metric analysis and reporting.
• Excellent written and verbal communication skills in English and Spanish.
• Ability to work in a team-oriented, matrix environment and work effectively with diverse departmental groups.
• Computer literacy, able to follow and implement instructions, work independently or as a team player, and collaborate with outside resources.
• Outstanding attention to detail and organization skills, effective decision making skills, focus on process improvements.

skills: Quality Assurance, GMP (Good Manufacturing Practice)
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
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