The Research Technician duties may include flow cytometry, data analysis, experimental design and method development; laboratory research with animals; gene cloning, sequencing, cryopreservation, PCR, PBMC processing, transfections, protein purification, immunohistochemistry, antibody binding kinetic analysis and characterization, and surface plasmon resonance).  Other immunological assays include Western Blots, ELISA, ELISPOT, and tissue culture. Applicants must possess a BA/BS in a physical or biological science with related experience.

• Performs all types of audits according to client expectations and/or company SOP’s.
• Interprets regulations and guidance documents governing GCP and applies the interpretation to daily work for the staff and client representatives.
• Supports and performs review and administrative tasks on new and updated Quality Management Documents (QMDs: SOPs).
• Hosts regulatory inspections and client audits of company to ensure that guest inspectors and auditors receive access to needed documentation and staff with minimal disturbance to ongoing operations.
• Other project related activities and duties as assigned

This position is full-time with flexibility on scheduling. Ideal candidate may be approved for alternative work schedule (i.e 4-10 hour days or split schedule including combination of office and remote, perfect for working parents who want to be home when school gets out).

Candidate will be required to travel an average of once a month.

Excellent Benefits Package which includes 11 Vacation Days, 22 Paid Time Off days, Full Benefits and matching 401k.  
 
JOB PURPOSE: Responsible for developing and maintaining the company’s Quality Assurance and Regulatory Compliance program (QARC). Areas of responsibility include, Clinical Compliance (GCP), Laboratory Compliance (GLP/GMP), Document Control and training administration programs.

KEY RESPONSIBILITIES AND ACCOUNTABILITIES
1. Establish and enforce standard Quality practices for the manufacture and release of products
2. Generate and maintain standard operating procedures, protocols, qualification and validation documents, chain of custody, and any other documentation necessary for regulatory compliance
3. Responsible for conducting, or organizing resources needed to conduct,

    a. internal and external audits and reviews
    b. support regulatory agency inspections
    c. administration of procedural documents
    d. quality oversight of R&D and external manufacturing.

4. Establish standard of quality for product manufacturing conducted by third party vendors.
5. Responsible for ensuring adequate procedures are in place for identifying, defining and directing activities of consultants involved in providing services subject to quality and/or regulatory compliance requirements.
6. Responsible for ensuring all staff are aware of applicable compliance requirements and responsibilities.
7. Responsible for maintaining document control system.
8. Foster a commitment to quality in individuals and a culture of quality within the organization.
9. Ensure coordination of audit follow-up and corrective action planning with appropriate functional areas.
10. Responsible for ensuring implementation of required corrective actions.
11. Ensure the preparations for, and management of, regulatory agency inspections (domestic and international). Ensure appropriate responses are prepared to any regulatory agency findings and are communicated in a timely manner.
12. Ensure that annual training plans are in place supporting needs of the organization and changes in regulatory requirements.

• Monthly review of all financial systems and issuance of profit and loss statements, head count reports and financial commentary
• Issuance of corporate and inter-company budgeted and actual cost of sales including production variances
• Prepare annual operating, head count and capital budget and quarterly forecasts
• Generate product standards based on operating budgets and site production plans. Monitor and reconcile balance sheet and profit and loss accounts for the site 
• Manage or participate in special projects as assigned including site cycle counts, cost savings initiatives, annual site objectives, and biennial inventory