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Quality Associate III

If you are looking for an opportunity that makes you feel appreciated every day, we invite you to join us at the American Red Cross! The American Red Cross Blood Services, Massachusetts Region has a proud heritage of providing quality blood products and services for hospital blood banks throughout Massachusetts, Maine, New Hampshire and Vermont.
Quality people make this happen and the New England Region actively looks for the brightest and best to help carry out our mission.
The American Red Cross is currently seeking candidates for our Quality Associate III position to work out of our Manchester, NH location.
Job SummaryReviews, assesses and monitors quality assurance programs, policies, processes, procedures and controlsensuring that performance and quality of products conform to establish standards and agency guidelines.
Leadsoperating entities in preparing for, hosting and closing out internal and external inspections/audits as necessary.
Works collaboratively with operations staff at all levels, to advance quality improvement efforts and leads culturechange by serving as an advocate and resource for quality programs and philosophy.
Perform all duties and responsibilities in compliance with standard operating procedures, Safety Quality IdentityPotency Purity (SQUIPP), regulations outlined in the Code of Federal Regulations (CFR), Occupational Safetyand Health Administration (OSHA) and other applicable Federal, state and local regulations.
Responsibilities1.
Reviews, assesses and monitors records, processes, and systems the manufacturing process and identifiesproducts/processes that are compromised and takes appropriate action.
2.
Trains/mentors QA staff and educates QA/operations staff on quality principles and regulatory requirements.
3.
Stops the manufacture, testing and/or distribution of biomedical products or services if the process orproduct is compromised.
4.
Leads operating entities in preparing for, hosting and closing out internal and external inspections/audits asnecessary5.
Participates in and functions as the QA lead for Operations and/or Quality Assurance meetings/projects toidentify quality issues, opportunities for standardization and/or process improvements and monitors changefor effectiveness.
6.
Represents QA in change control, standardization and consolidation activities to ensure implementationoccurs in a state of compliance.
(no adverse impact).
7.
Performs related duties as assigned.
The above statements are intended to describe the general nature and level of work being performed.
They arenot intended to be an exhaustive list of all responsibilities and duties required of staff so classified.
Bachelor's degree in applicable field or equivalent related experience.
Five years experience in a GMPenvironment such as blood banking, pharmaceutical, medical devices or a hospital, to include two yearsexperience in QA, QC or Quality Auditing.
Knowledge of federal regulatory requirements pertinent topharmaceutical, biologic or medical device manufacturing.
Good analytical and problem solving skills.
Demonstrated effective verbal and written skills.
Strong analytical and problem solving skills.
Strong skillsneeded to advance compliance and quality in operations; must deal effectively with management and staff inareas, 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 ofsensitive information in the department.
Must operate as a team member.
To apply for this position, please visit our website at www.
americanredcross.
apply2jobs.
com and reference REQ# BIO53571.
We are an Equal Opportunity/Affirmative Action Employer.
EOE/AA and M/F/D/V As an Affirmative Action/Equal Opportunity Employer, well-qualified women, minorities, veterans and persons with disabilities are encouraged to apply .
Qualifications:
Bachelor's degree in applicable field or equivalent related experience.
Five years experience in a GMPenvironment such as blood banking, pharmaceutical, medical devices or a hospital, to include two yearsexperience in QA, QC or Quality Auditing.
Knowledge of federal regulatory requirements pertinent topharmaceutical, biologic or medical device manufacturing.
Good analytical and problem solving skills.
Demonstrated effective verbal and written skills.
Strong analytical and problem solving skills.
Strong skillsneeded to advance compliance and quality in operations; must deal effectively with management and staff inareas, 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 ofsensitive information in the department.
Must operate as a team member.


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