OctaPharma Plasma Donor Center Director in Forestville, Maryland

Requisition Number

16-3334

Post Date

12/1/2016

Title

Donor Center Director

City

Forestville

State

MD

Position Type

full-time

Description

If you are interested in an exciting career in the biopharmaceutical or medical field you’ve come to the right place. At Octapharma Plasma you can channel your passion for helping others into a medical career that is fast-paced and personally and professionally

rewarding. Whether you are just beginning your career or you have experience in the medical field, we have many exciting opportunities for you to consider.

The Center Director manages and oversees donor center staff and operations, including production, quality compliance, finance, HR, and IT. Acts as a liaison with all corporate functions to ensure center compliance and performance. Maintains compliance with

SOP, current Good Manufacturing Procedures (cGMP), and regulatory guidelines

Additional Responsibilities Include:

Maintains FDA Compliance

  • Ensures the performance of all center activities in conjunction with the SOP and other company standards and protocols.

  • Oversees the performance of preventive maintenance of donor center equipment to ensure that the equipment is well-maintained and in good working order.

  • Ensures the facility is well-maintained, clean, and neat at all times.

  • Maintains a thorough understanding of state and federal regulations (e.g. FDA approved Standard Operating Procedures, OSHA, CLIA, and GMP) to maintain the highest production standards and ensure facility compliance.

  • Reviews test results to ensure that abnormal and reactive test results including unit quarantine, computer entry, execution of look backs, and final disposition of product.

  • Maintains donor center regulatory compliance at all times.

  • Complies with federal, state, local and company-specific regulations related to quality of product, employee and donor safety and to the proper performance of day-to-day activities.

Problem Resolution

  • Maintains all aspects of daily center functions (e.g. personnel, products, donors, computers, etc.).

  • Keeps immediate supervisor informed of any irregularities within the center and provides constructive information about process improvements.

  • Minimizes center liability through constant risk management review, including review of Medical Incident Reports, minor incident logs, and driving effective, timely corrective actions.

Product Shipment and Sample Submissions

  • Ensures that product shipments and sample submissions are accurate and performed in accordance with shipping schedules.

  • Ensures that center is in compliance with directives on shipping listed in the SOP and instructions provided by the corporate logistics group.

  • Maintains freezer and refrigerators within required temperature ranges.

  • Intervenes to ensure product integrity as required.

  • Held accountable for freezer inventories.

  • Responds to freezer alarms per SOP.

Budget and Fiscal Control

  • Maintains a professional and courteous relationship with donors that will stimulation donor retention, referrals, and production grow

  • Ensures projected production budget is met in both quantity and potency.

  • Ensures cost-effective purchasing of products by maintaining accurate inventory of supplies and goods.

  • Ensures that purchase orders are filled out completely, approved, and submitted to the accounting department according to the Accounting Procedures Manual.

  • Completes and monitors payroll records to ensure employee hours are used efficiently.

  • Responsible for all phases of cash/check payments to donors.

  • Monitor donor retention and implement plans for improvement.

  • Monitor all marketing and advertising and work with appropriate corporate departments to identify necessary changes to marketing and advertising.

Organizational Leadership and Effectiveness

  • Trains, develops, and manages all staff in accordance with the Human Resources and company policies and other established management guidelines and regulations.

  • Ensures adherence to all HR policies and procedures through fair and equitable treatment of all employees.

  • Hires, motivates, and evaluates center personnel based on established guidelines.

  • Disciplines and terminates center employees and maintains complete, accurate personnel records.

  • Ensures adequate, trained staff is available to cover the hours of operation in adherence to regulatory requirements.

  • Creates an organizational environment that stimulates the morale and productivity of the work force and its leadership.

  • Provides leadership for employee relations through effective communications, coaching, training, and development.

  • Drives initiatives to the management team that contributes to long-term operational excellence.

  • Performs employee performance reviews.

  • Performs other related duties as assigned.

  • Contributes to formulating area schedules to best accommodate production levels and donor arrival patterns.

  • Acts as person accountable for area operations including break schedules.

  • Trains and provides leadership to new/existing employees.

  • Provides positive and effective guidance to Processing Technicians.

  • Reallocates area resources to alleviate process flow issues to ensure timely storage of collected plasma and minimize the donors’ time in the center.

  • Ensures prompt and sterile collection of plasma samples using electric heat sealer and centrifuge.

  • Complies with federal, state, local and company-specific regulations related to quality of product, employee and donor safety and to the proper performance of day-to-day activities.

  • Ensures samples and bottles are properly organized in large storage freezer in allotted timeframe as well as in the donor management computer software.

  • Handles tested and untested product as well as plasma with unsuitable test results with properly utilized personal protective equipment.

  • Prepares units and samples for regular daily and weekly shipments per company policies and strict federal transportation regulations.

  • Performs all required quality controls and legibly records the results on the appropriate logs and into the donor management computer software.

  • Reports quality issues and procedural deviations to Quality Assurance and Management.

  • Greets and builds rapport with donors and directs them to appropriate areas for further processing.

  • Answers the telephone and any donor inquiries regarding the procedure, payment, and company policies in a prompt, professional manner.

  • Maintains donor flow while adhering to standard operating procedures.

  • Remains professional at all times in a fast-paced environment with frequent interruptions.

  • Ensures all donation information is complete, accurate, and legible after donation.

  • Follows all OSHA requirements and company personnel policies.

  • Remains alert for any adverse donor reactions and notify appropriate staff.

  • Maintains confidentiality with all specific donor issues and record keeping activities.

  • Stocks and maintains an orderly work area with sufficient supplies to meet production demands.

  • Cleans and maintains equipment on a daily basis and troubleshoots issues as they arise.

  • Cleans any blood or plasma spills and performs proper procedure for disposition of biohazardous waste.

  • Monitors freezer and refrigerator temperatures and immediately informs appropriate personnel if equipment is not functioning properly. Records variance, if applicable.

  • Conducts daily calibration of equipment according to appropriate SOPs.

  • Performs other job related tasks as assigned.

Requirements

  • Bachelor’s degree in Biological Science or Business Administration preferred or equivalent experience.

  • Three to five years of working experience in a biomedical field preferred.

  • Previous work experience demonstrating decision making ability, ability to effectively communicate with and positively influence people, familiarity with fiscal operations, supervisory responsibility, conflict resolution, and customer service.

  • Certification as a Sr. Medical Screener, Phlebotomist and Sr. Processing Technician required or ability to obtain certification within six months of acquiring position. Where state licensure is required for one of these positions, a clear understanding

of the procedures can substitute.

  • Basic organization, multi-tasking, and problem-solving skills and the ability to work well under pressure and meet demanding deadlines.

  • Basic computer, typing, and mathematical skills.

  • Proficiency with Microsoft Office Suite (Word, Excel).

  • Excellent communication skills and ability to conduct oral presentations.

  • Excellent people skills which extends to a diverse group individuals and demographics.

  • Ability to speak, writes, and read English. Bilingual abilities may be required in some locations.

  • Ability to work day and evening hours, weekends, holidays, and extended shifts on a frequent basis.

  • Professional appearance and demeanor.

Octapharma Plasma offers competitive compensation and benefits including medical, dental, vision, life insurance, 401(k) and tuition reimbursement.