Quality Associate II

Job Description

Quality Associate II General Requirements

This position will require the employee to fulfill the following general requirements for employment at Allermed Labs and includes but limited to:

Practice good hygiene and personal sanitation practices.

Compliance with cGMPs and applicable standard operating procedures

Compliance with company environmental health and safety procedure

Protect and preserve Allermed physical property and equipment.

Protect and preserve Allermed intellectual property and confidential information.

Quality Associate II Education Requirements

This position requires the following minimum education:

High School Education

Bachelor’s degree (BA/BS) preferred

Quality Associate II Skills/Work Experience Requirements

Minimum of 3 years of experience in Pharmaceutical or Biologics industry.

Minimum of 3 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.

Quality Associate II Specific Job Requirements

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

Quality Associate II 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

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.

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.