QA Specialist - II

Spectraforce Technologies; El Segundo (CA); On-site; USD 65,000 - 90,000; Full time

Job summary

Spectraforce Technologies seeks a QA Specialist II for our El Segundo, CA location. You will execute a variety of quality activities to ensure compliance with quality objectives and regulatory requirements, reporting to the Sr. Manager of Quality Assurance Operations.

Expected work includes M-F with occasional weekend/night shifts during manufacturing campaigns. Join a fast-paced environment where you will provide QA oversight for deviations, CAPA, and related records, ensuring timely

Qualifications

• The candidate should have a strong foundation in quality assurance practices.
• Experience or education related to biological sciences is favorable for validation of QA processes.
• Familiarity with regulatory requirements and change control is preferred.

Responsibilities

• Provide QA oversight and approval of deviations, OOS, and change control records with moderate to high complexity.
• Review CAPA and EV records and ensure timely initiation and closure.
• Escalate deviations per procedures and support CAPA processes during campaigns.
• Support in-process and final product QA issues at the El Segundo site.
• Collaborate with cross-functional teams to ensure compliance and alignment with QA objectives.

Education

Master's Degree

Bachelor's Degree

AA Degree

High School Degree

Tools

MS Word

Excel

PowerPoint

Job description

Job Title: QA Specialist - II

Location: El Segundo, CA 90245

Duration: 7 Months (Possibility of extension depending upon business requirements and performance)

Job Description

• The client is seeking a highly motivated individual to join us as a Quality Assurance Specialist II.


• In this role you will be responsible for executing a variety of Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.


• You will be located at our El Segundo, CA site and report into the Sr. Manager of Quality Assurance Operations.


• The standard work week for this position is M-F, however weekend/night work will be required during manufacturing campaigns to support process operations

Key Responsibilities (include but are not limited to)

• To provide QA oversight and approval of deviation, OOS, and change control records that have moderate to significant levels of complexity and/or novelty. Ensure records are properly initiated, investigated and resolved in accordance with established timelines.


• To provide QA oversight and approval of CAPA and EV records that have moderate to significant levels of complexity and/or novelty. Ensure CAPAs are initiated and resolved in a timely manner.


• Ensure escalation of deviations per procedures


• Identify efficiencies in the execution of the Deviation ad CAPA processes at TCF03 in a compliant manner


• Provide QA support resolving in-process product, final product, manufacturing, environmental, facility and equipment and material issues.


• Additional duties as assigned.


• These duties can be delegated to designated deputies of a satisfactory qualification level as needed.

Basic Qualifications

• Master's Degree and


• Bachelor's Degree and 2+ years' experience in the biological sciences or related field


• AA Degree and 4+ years' experience in the biological sciences or related field


• High School Degree and 5+ years' experience in the biological sciences or related field

Preferred Qualifications

• Quality Control background in Analytical, Virological, and Microbiological testing


• Working knowledge and ability to apply GMPs in conformance to U.S. and EU standards


• Ability to effectively negotiate and build collaboration amongst individuals


• Proficient in MS Word, Excel, Power Point and other applications.


• Excellent interpersonal, verbal and written communication skills are essential in this collaborative work environment


• Comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities