Quality Assurance Specialist I, Sun-Wed 7A-5P

QA Specialist I– Burlington, MA
Sunday-Wednesday, 7am-5pm or Wednesday-Saturday, 7am-5pm

The Quality Assurance Specialist I is responsible for maintaining Quality databases and providing on-the-floor QA presence and oversight to the manufacturing operation. The QA Specialist’s role will include identifying compliance risks in the operation prior to and during execution, avoiding deviation whenever possible as well as managing immediate corrective action such that a) adherence to cGMP’s and internal procedures/policies is maintained, b) appropriate immediate corrective action is implemented and effectively documented in order to provide traceability and substantiation of any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and assist in the initiation and resolution of deviations.

Join our talented workforce, where a commitment to excellence and a customer-focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture.

Responsibilities:

• Educate and train manufacturing/process engineering personnel to execute production in full accordance with cGMP’s and CURIA’s quality system to ensure real-time compliance.
• Represent CURIA Quality Assurance when managing issues that require immediate corrective action. Ensure such action taken is appropriate and appropriately documented.
• Reviews Un-executed /Executed batch records and quality control testing for compliance with internal SOPs and specifications
• Monitor Operations personnel for adherence to SOP’s. Report back to Supervisor of QA as well as area functional management as to personnel performance, highlighting those areas and individuals in need of improvement
• Reviews and approves Document Change Notifications for SOPs, test methods, raw material specifications, protocols (stability, validation, etc.) and batch records
• Reviews and approves SOPs, test methods, raw material specifications, protocols and executed validation documentation
• Authors or revises SOPs
• Performs manufacturing area and labeling clearances as well as inspection of material
• Reviews and approves CAPAs, Deviations, Change Controls, Equipment Excursion Reports
• Assists in performing investigations
• Performs daily walkthroughs with Manufacturing personnel
• With supervision, may respond or manage responses to clients regarding manufacturing and/or documentation issues
• Assists tracking and follow-up on Deviations, Change Controls, Investigations, and CAPAs
• Develops and/or maintains Quality System metrics for Management Review
• Provides on the floor support to manufacturing operations
• Perform QA visual inspection activities associated with clinical and commercial drug product.
Participate in regulatory and client audits.

Qualifications: ( To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.)

• Bachelor’s degree (or foreign equivalent) in Biology, microbiology, biotechnology or related life science field.
• Minimum 0-3 years’ GMP and QA experience in an FDA-regulated pharmaceutical environment for level I.
Working in a cleanroom environment is preferred.

The Company is an equal opportunity employer and provides employment opportunities and makes employment decisions without regards to an individual’s disability or religion or on any other basis prohibited by applicable law. All interested applicants must apply online. Curia is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Knowledge, Skills & Abilities:

• Excellent written and verbal presentation and communication skills
• Strong facilitation skills
• Strong problem solving skills, with the ability to resolve conflict
• Ability to effectively present information to management and/or peers
Comfortable working independently in combination with individuals in other departments across the organization

All interested applicants must apply online. Please be aware of scammers. Curia will only send offer letters and requests for sensitive personal information from a curiaglobal.com email address. CURIA is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.