Job Listing Description

Quality Specialist II

Chipton-Ross is seeking a Quality Specialist II for an opening in Ward Hill, MA.

Responsible for determining non-conforming products and materials disposition (implementing QA quarantines and/or release of affected inventory). Gathers information from multiple departments (Customer Service, Product Specialists, Product/Process Owners and Regulatory) in order to assist RA and process owners with the determination of risk related to a reported Nonconformance. Responsible for the assignment of CAPA reports (corrective/preventive action requests) to NCRs. Ensure all nonconforming product(s) are identified and removed from use. Ensure completion and accuracy of all associated quality records related to nonconformance and CAPA reports. Assist with the performance and documentation of Internal Audits and support External Audits, as required. Lead and/or participate in product related team meetings and/or performance reviews, as needed. Assist with QA department functions as needed. (Specific duties may vary and will be documented in department records, job assignments and/or project action items). Perform computer operations for data entry, and provide tracing/trending reports. Additional support of routine QA department standard operating procedures (SOPs) is also expected when necessary.

Two (2) years of experience in a Quality regulated environment. Able to create presentations, work with spreadsheets, prepare reports and write procedures utilizing MS Word, Excel and PowerPoint software applications.

Preferred Qualifications:
Background in diagnostics.

Knowledge of:
Detailed knowledge of ISO and GMP regulations which govern a medical device and diagnostics manufacturing. Knowledge of statistical process controls and GMP CAPA requirements. Tracking and trending tools and reporting techniques.

Ability to:
Provide accurate QS tracking and trending reports. Good procedural writing skills a plus. Exercise independent discretion and judgment in execution of duties. Plan and organize oneself in a consistent manner. Be a self-starter with the ability to positively motivate others in a cooperative fashion. Establish and maintain effective working relationships with other staff members. Effectively communicate both orally and in writing to management, customers and regulatory personnel. Maintain confidentiality of sensitive laboratory information; perform computer operations for data entry.

Accredited Bachelor's degree in Biological Sciences or a related field

1st Shift
Job Number: 191553
Job Location: Ward Hill, MA
Rate: Up to $35.00 DOE
Duration: 7 mos
Input Date: 05/26/2021
Last Updated: 06/20/2021
Attention: Tyler Harrell
Address: 420 CULVER BLVD
City, State: PLAYA DEL REY, CA 90293
Phone: 310/414-7800 X286
800 Phone: 800/927-9318
Fax Phone: 310/414-7808

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