Quality Assurance Associate II (Dedham, MA)

Job Description

• The American Red Cross requires all new hires be vaccinated against COVID-19 as a condition of employment. This means that all individuals working for the organization must be fully vaccinated against COVID-19 by the start of their employment OR have begun the vaccination process prior to their start date. Upon being offered a position, individuals will be required to submit proof of vaccination. If you are unable to be vaccinated due to medical or religious reasons, you may qualify for an exemption. If seeking an exemption, you will be required to submit documentation and your request must be approved prior to hire.

Responsibilities

• Reviews, assesses and monitors records, processes, and systems at the critical control points in the manufacturing process.
• Monitors the implementation and effectiveness of corrective actions.
• Stops the manufacture, testing and/or distribution of biomedical products or services if the process or product is compromised.
• Assists and/or leads operating entities in preparing for, hosting and closing out internal and external inspections/audits as necessary.
• Identifies manufacture, testing and/or distribution of biomedical products or services that are compromised and takes appropriate action.
• Participates in Operations and/or Quality Assurance meetings for review of quality concerns.
• Identifies and participates in process improvement and standardization activities and monitors change for effectiveness.
• May represent QA on projects, work groups or process improvement teams
• Participates in and/or leads internal quality reviews of critical areas, operations, and processes.

Qualifications

• Bachelor’s degree in applicable field of study or equivalent job experience.
• Three years experience in a GMP environment such as blood banking, pharmaceutical, medical devices or a hospital.
• Two years experience in QA, QC or Quality Auditing. Knowledge of federal regulatory requirements pertinent to pharmaceutical, biologic or medical device manufacturing.
• Good analytical and problem solving skills. Demonstrated effective verbal and written skills. Strong analytical and problem solving skills.
• Strong skills needed to advance compliance and quality in operations; must deal effectively with management and staff in areas, at BHQ, and outside the organization.
• Persuasive skill to achieve compliance with relevant procedures.
• Must display tact, diplomacy and professionalism in difficult situations.
• Must protect the confidentiality of sensitive information in the department.
• Must operate as a team member.

Apply now! Joining our team will provide you with the opportunity to make a difference every day.

The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

• Standard Equivalent Code Standard Equivalent Code

Apply now! Joining our team will provide you with the opportunity to make a difference every day.

The American Red Cross is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law.

Interested in Volunteering?

Life’s emergencies don’t stop, and neither do American Red Cross volunteers, who represent more than 90 percent of our workforce to help prevent and alleviate human suffering. You can make a difference by volunteering in a position that appeals to you and allows you to use your unique skills and talents. The Red Cross relies on generous volunteers who give their time and talent to help fulfill our lifesaving mission.

Visit redcross.org/volunteertoday to learn more, including our most-needed volunteer positions.

To view the EEOC Summary of Rights, click here: Summary of Rights