Overview:

The Center Medical Director works under the supervision of the Division Medical Director, for professional competency matters, and the Center Management for administrative matters. It is his/her responsibility to follow and be compliant with the guidelines and regulations of the Food and Drug Administration (FDA) and the company's Standard Operating Procedures (SOP), and all applicable regulatory agencies to ensure proper donor assessment in regards to their suitability as a plasma donor and product integrity.

Responsibilities:

- Serve as recognized Center Medical Director for all verbal and/or written correspondence to state Department's) of Health and other regulatory agencies, as necessary and, as such, has direct supervisory responsibilities of the center staff regarding medical processes and donor selection.

-Selection of suitable plasmapheresis donors through the use of FDA approved Standard Operating Procedure manual, current State and Federal guidelines, OSHA, CLIA, cGMP, pertinent sections of the CFR all internal company procedures as well as personal education and experience.

- Observe and confirm compliance of the Center's medical and laboratory procedures as they affect the safety of the donors and the final product and provide feedback to Center Management Team.

- Responsible for the certification, training and performance of the center medical staff as it pertains to the donor assessment and to compliance with the Company's standard operating procedures (SOP).

- Provide additional necessary training, re-certification and corrective actions for the center's Medical Staff.

- Provide guidance and certification of the center's medical staff regarding the appropriate and confidential counseling to individuals with unacceptable results, and the appropriate level of care during unusual or severe donor reactions.

- Timely review of accumulated data to confirm established donor suitability, donor safety and product safety.

- Oversight and training of donor immunization program, if available at the center, according to established protocol.

- Promote customer satisfaction through appropriate interaction and responsiveness to customer needs.

- Recommend changes and improvements to Standard Operating Procedures

- Meet with all the center medical staff on a regular basis to provide further development of their skills and knowledge as it pertains to their functions at the center.

- Participate and collaborate with center's CLIA, Safety, Quality meetings and other meetings as necessary.

- Provide education sessions to the center medical staff according to the Company's standard operating procedures (SOP).

- Learn, understand and be independent working with the NexLynk system as it relates to the duties and responsibilities of this position.

- Review and approve the CLIA defined moderate complexity test procedures, as appropriate.

- May act as Technical and/or Clinical Consultant for all CLIA regulated testing in compliance with the responsibilities outlined in 42 CFR, Part 493,k Laboratory Requirements, Subpart M, Sections 493.1413 and 493.1419, Standards; Technical Consultant and Clinical Consultant responsibilities respectively.

- If meets CLIA criteria to be certified as technical or clinical consultant, complete the CLIA competency assessment for all employees who perform CLIA designated moderate complexity tests according to regulatory guidelines.

- If meets CLIA criteria to be certified as technical or clinical consultant, review results of moderate complexity tests and proficiency testing by the plasma center staff as required.

- Review the QA reports for timely and appropriate actions on moderate complexity procedures for test problems.

- As requested, provide a copy of the current medical license, curriculum Vitae, diplomas, and other documents to fulfill State, Federal and company requirements.

- Be available for monthly meetings with the Division Medical Director.

- Comply with all contract agreements.

- Other duties as assigned.

Requirements:

- M.D. or D.O. Current, and unrestricted physician licensed in the state in which the center operates is required. Evidence of fulfillment of CLIA requirements as technical or clinical consultant for a Laboratory of Moderate Complexity. CPR is required with Automated External Defibrillator (AED) experience.

- Typically requires a 0 to 2 years of related experience.

- Occupational Demands Form # 75: Work is performed in a plasma center. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to electrical office and laboratory equipment. Exposure to extreme cold below 32 degrees F while performing functions in plasma freezers. Personal protective equipment required such as protective eyewear, garments, gloves and cold-gear. Work is performed both standing and sitting for up to 2 to 4 hours per day each. The position does require bending and twisting of neck up from 1 to 2 hours per day. Frequent hand movement of both hands with the ability to make fast, simple, movements of the fingers, hands, and wrists. Ability to make precise coordinated movements, of the fingers to grasp and manipulate objects. Frequent foot movement; may squat, crouch or sit on one's heels on rare occasion. Occasionally walks, bends and twists at waist. Light lifting of 15lbs. with a maximum lift of 50lbs. May reach below shoulder height. Hearing acuity essential. Color perception/discrimination, near vision and far vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences. Works independently and within guidance of oral or written instructions.

Performs a wide range of tasks as dictated by variable demands and changing conditions. Relates sensitive information to diverse groups.

Job Type: Contract

Pay: $130.00 - $150.00 per hour

Expected hours: No more than 4 per week

Schedule:

• 4 hour shift

Ability to Commute:

• Harrisburg, PA 17110 (Required)

Work Location: In person