Quality Assurance Associate I

Specific Job Requirements

This position requires the ability to perform but not limited to the following tasks:

Responsibilities:

Manufacturing Quality Assurance related activities include but are not limited to:

• Effectively communicate and collaborate with internal Quality Assurance, Manufacturing, Quality Control and Facilities teams
• Issue and review executed production batch records and associated testing data to ensure the records meet cGMP expectations
• Participate in QA team meetings
• Supports the use of and maintains Quality trackers as assigned
• Align daily actions with department goals and company culture
• Drive the spirit of teamwork across all functions by supporting a team approach with focus on our patients being the top priority
• Fosters and embraces an environment of teamwork, accountability and responsibility that supports the manufacture of a quality product
• Controlled document review and /or batch release experience preferred
• Ability to open, investigate and effectively close Deviations, CAPAs and Change Control processes
• Ability to work independently, within prescribed guidelines, and as a team member
• Demonstrated ability to work effectively in a dynamic, complex and fast-paced team environment
• Ability to support a flexible work schedule to accommodate the Allermed Manufacturing schedule

Additional Requirements/Responsibilities

• Work in a team environment; including ability to organize, prioritize and promote team work.
• Draft quality assurance policies and procedures
• Interpret and implement quality assurance standards
• Evaluate adequacy of quality assurance standards
• Devise sampling procedures and directions for recording and reporting quality data
• Review the implementation and efficiency of quality and inspection systems
• Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality
• Conduct internal and external audits
• Document internal and external audits and other quality assurance activities
• Investigate customer complaints and non-conformance issues
• Collect and compile statistical quality data
• Analyze data to identify areas for improvement in the quality system
• Develop, recommend and monitor corrective and preventive actions
• Prepare reports to communicate outcomes of quality activities
• Identify training needs and organize training interventions to meet quality standards
• Coordinate and support on-site audits conducted by external providers
• Evaluate audit findings and implement appropriate corrective actions
• Monitor risk management activities
• Assure ongoing compliance with quality and industry regulatory requirements.

Education Requirements

This position requires the following minimum education:

• High School Education
• Bachelor’s degree (BA/BS) preferred

Skills/Work Experience Requirements

• Minimum of 1-2 years of experience in Pharmaceutical or Biologics industry.
• Minimum of 1-2 years of experience in Quality Assurance and Quality Inspection and testing.
• Computer skills including Microsoft Office Word and Excel.
• Ability to comprehend math including ratios, multiplication, division, addition and subtraction.
• Position requires strong attention to detail, logical thinking, and an aptitude for multitasking.

Physical Demand(s)

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is frequently required to sit and talk or hear. The employee is occasionally required to stand; walk and use hands to finger, handle, or feel. Specific vision abilities required by this job include close vision and ability to adjust focus.

Job Type: Full-time

Pay: $60,000.00 - $70,000.00 per year

Benefits:

• 401(k) matching
• Dental insurance
• Health insurance
• Vision insurance

Schedule:

• Monday to Friday

Application Question(s):

• How much experience do you have in Pharmaceutical or Biologics industry?

Education:

• Bachelor's (Preferred)

Ability to Commute:

• San Diego, CA 92111 (Required)

Work Location: In person

Salary : $60,000 - $70,000