Quality Assurance Associate II (Dedham, MA)

Job Description:

Responsibilities

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

WHAT YOU NEED TO SUCCEED:

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.

BENEFITS FOR YOU:

As a mission-based organization, we believe our team needs great support to do great work. Our comprehensive package includes:

Medical, Dental Vision plans

Health Spending Accounts & Flexible Spending Accounts

PTO: Starting at 15 days a year; based on type of job and tenure

Holidays: 11 paid holidays comprised of six core holidays and five floating holidays

401K with up to 6% match

Paid Family Leave

Employee Assistance

Disability and Insurance: Short + Long Term

Service Awards and recognition

The American Red Cross is an Equal Opportunity 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.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers, San Diego Fair Chance Ordinance, the California Fair Chance Act and any other applicable state and local laws.

AmeriCorps, the federal agency that brings people together through service, and its partners - the Peace Corps, AmeriCorps Alums, National Peace Corps Association, and the Service Year Alliance - launched Employers of National Service to connect national service alumni with opportunities in the workforce.American Red Cross is proud to be an EONS partner and share our employment opportunities with the network of organizations.

Interested in Volunteering? 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