Quality Manager

Description

Position Description: The Quality Assurance Manager will perform under the supervision of Quality Assurance corporate management, and at times will take instruction and tasks from the Center Manager and other Corporate Management. The Quality Assurance Manager will ensure donor suitability, product integrity and the continued good health of donors through the compliance with Food and Drug Administration (FDA) regulations, European Union (EU), state regulations, the Standard Operating Procedure Manual guidelines of the Company and any other applicable regulatory standards.

Essential Duties and Responsibilities (the following list is intended to be a guideline. Other duties and responsibilities may be assigned):

Quality Assurance Manager

Ensuring all center operations, product storage, documentation, facility maintenance, quality control, and training is consistent with the Company’s Standard Operating Procedure Manual (the “SOPs”), current State and Federal guidelines, EU, OSHA, CLIA, cGMP, and any other internal Company procedures

• Overseeing all Quality Assurance functions at collection center
• Overseeing all Quality Assurance management at the Cherry Hill center including, but not limited to, approval of Paid Time Off (PTO) and performance appraisals, if applicable
• Periodic or regular review, as needed, of center documentation such as donor records, logs, forms, test results, proficiency testing, and equipment validations/qualifications
• Report to the Center Manager any errors/incidents/events that may affect the safety, purity, identity, or quality of blood products
• Reporting to the Center Manager and overseeing the handling of all product recalls and market withdrawals according to established procedures and guidelines
• Ensuring that regular audits are performed at the center by Quality Assurance management. Audits of operations and procedures are performed to ensure compliance with all SOP, regulations, and internal Company procedures, including competency evaluations of all center personnel. Audits can be performed independently or at the request of center/corporate management
• Ensuring all issues reviewed and closed in a timely manner, with as maximum of 30 days provided for issues that require a lengthier investigation. If the 30-day timeframe cannot be achieved a notation should be in the issue as to why it cannot be achieved
• Overseeing the equipment qualification process including receipt of new equipment, sending equipment out for repairs, qualifying new equipment, maintaining the equipment calibration calendar, and performing annual equipment calibrations when necessary
• Trending of all incidents/issues, complaints, and Planned Deviations within the center
• Ensuring employee training is completed per Company SOP and other regulations
• Controlling the release/issuing of reagents
• Acting as a point person for all external audits at center. Overseeing the Center Management/Quality Assurance Management response to external audit citations, including Corporate audits of the center.
• Ensuring overall center compliance with all regulations/accreditations
• Ensures each employee/function in the center is provided with and had ongoing access to the necessary SOPs to perform assigned duties
• Performing lot release procedures of incoming soft goods and control of labels used on blood products
• Maintaining NDDR access and data as a company manager
• Reviewing all NDDR entries and reviewing all notification to state agencies regarding donors who have confirmed positive test results in accordance with SOP B 4.03 (External Agency Notification Regarding Permanently Deferred Donors)
• In the event center management is absent from operations, Quality Assurance may submit donors into the NDDR so long as a secondary review from another qualified individual occurs. Quality Assurance is also responsible for reviewing issues related to NDDR corrections
• Abiding by the signed management confidentiality agreement, and ensuring that records and data printed from the NDDR are kept in a confidential area of the center or destroyed by shredding these printed records
• Overseeing final release and shipment of product
• Respond to freezer alarms and help coordinate emergency procedures, if needed
• Other duties as assigned

Requirements

Education and Experience:

• Bachelors degree in Business, Engineering, or field related to the products being developed required.
• Three to five years of experience in related field required with supervisory experience a plus.

Required Skills/Abilities:

• Communication.
• Consultation.
• Ethical Practice.
• Cultural Awareness.
• Business Acumen