Quality Assurance Specialist

General Summary

The Quality Assurance Specialist assists with planning, coordinating, monitoring and performing functions related to the Quality Management System QMS) while ensuring that Origin Biologics maintains compliance to all regulatory requirements.

Functional Responsibilities

• Ability to support the implementation and daily maintenance of the QMS in compliance to the regulations including but not limited to FDA 21 CFR Parts 110, 820, 1270, 1271, 13485, and ISO 9001. and in support of the manufacturing and distribution of Class II medical devices and allograft derived products.
• Assists with development and writing of Policies, Standard Operating Procedures, Work Instructions, Training Manuals, and all other documentation required in accordance with established and current quality requirements.
• Facilitates collaborative and interactive communications and engagement with Origin Biologics management teams to ensure ongoing development of processes for regulatory compliance alignment and identification of opportunities for improvement required to maintain efficient work practices within the facility.
• Assists with the development and implementation of continuous process improvements.
• Provides QMS reports related to quality and regulatory compliance to of Quality & management.Coordinates the design, collection and monitoring of key quality performance metrics and provides metric reports to departmental management.
• Facilitates the performance of internal assessments and audits in order to assess regulatory compliance and the effectiveness processes. Provides assessment and audit report to upper management.
• Assists with the development and ongoing maintenance of the equipment program.Ensures scheduling and completion of scheduled and unscheduled maintenance is performed and document per established procedures.
• Assists with equipment and electronic system validation and verification process.This includes and is not limited to providing support with protocol writing, approval, and execution.The QA Specialist will be responsible for ensuring validation reports are effectively written and approved to ensure the integrity of the asset performance. Assist with ensuring all revalidation and verifications are scheduled and performed as required.
• Performs tasks related to the general administration of the company’s Quality Management System, including but not limited to; management and timely closure of Non-Conformances, CAPAs and Change controls
• Assists in the creation, management, scheduling, performance, and documentation of personnel training and competency on regulations including GMP, GTP, and QMS.
• Assist with the preparation of monthly quality metrics and system trending for reporting.
• Performs other duties as required or assigned.

Non-Functional Responsibilities:

• Ability to promote the organization, its vision and reinforce brand awareness and visibility
• Assist management with representing the organization at events, functions, society and conference meetings
• Ability to engage and motivate OB team members on the QMS through strong and effective communication
• Ability to provide agile, creative solutions to expedite go-to-market strategies
• Interact with internal and external customers to ensure the best possible QA/RA customer experience

CULTURE:

• Dynamic, fast paced start-up environment
• Relentless focus on execution, accountability, quality and delivery schedule
• Apply agile and creative solutions to build disruptive business model

Job qualifications

• A/B.Sc. in physical, applied and/or life sciences, engineering or mathematics is required. Or;
• At least five (10) years of Relevant long term-term experience, knowledge of regulatory requirements in the related industry or with related products.
• Experience with American Association of Tissue Banks (AATB) and International agencies (Australia, Asia, South and Central America and Mexico) and European Medicines Agency (EMA)is preferred.
• Knowledge of QA terms, tools and methodologies
• Circumspect problem-solving skills and good mathematical and computer skills including competence in Microsoft Office required
• Maintains a current working knowledge of all relevant laws, regulations and industry applicable standards(GMP, GTP, ISO 13485, FDA 21 CFR 1271 and 21 CFR 820 ).
• Work requires the mental ability and supervisory skills necessary to implements and oversee the documentation requirements necessary to conform to the standards of the procedure manual, AATB standards, OSHA requirements and all other relative agencies.

Job Type: Full-time

Pay: $50,000.00 - $80,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift

Supplemental Pay:

• Signing bonus

Education:

• Associate (Required)

Experience:

• quality assurance: 1 year (Required)
• medical device or tissue processing: 1 year (Preferred)

Work Location:

• One location

Visa Sponsorship Potentially Available:

• No: Not providing sponsorship for this job

This Company Describes Its Culture as:

• Detail-oriented -- quality and precision-focused
• Team-oriented -- cooperative and collaborative
• People-oriented -- supportive and fairness-focused

Benefit Conditions:

• Waiting period may apply
• Only full-time employees eligible

Work Remotely:

• No

COVID-19 Precaution(s):

• Personal protective equipment provided or required
• Temperature screenings
• Sanitizing, disinfecting, or cleaning procedures in place