Quality Assurance Manager

KEDPLASMA provides a friendly and rewarding working environment with frequent opportunities for cross-training and advancement. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.

Please be advised that our organization participates in E-verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. For more information on E-verify, please contact the Dept. of Homeland Security.

Kedrion Biopharma & KEDPLASMA offer a number of benefits to qualifying employees, including:

• Medical, vision and dental insurance

• Life and AD&D insurance

• Paid holidays

• PTO accrual

• and much more

Please let us know if you would like further details regarding the benefits that we offer to our qualifying employees, and we would be glad to provide you with our full benefits guide, as well as answering any questions you may have

Please note that salary ranges are calculated based off levels of: relevant experience, education and certifications.

JOB SUMMARY

Manages plasma collection centers' Quality staff and ensures quality standards are met with authority to stop production and/or plasma shipment release. Supports strategies and assures the company image as an ethical and high-quality provider of plasma is developed and maintained. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR.

ESSENTIAL JOB FUNCTIONS

Every effort has been made to make your job description as complete as possible. However, that in no way states or implies that these duties/responsibilities are the only duties you will be required to perform. The omission of specific duties/responsibilities does not exclude them from the position if the work is similar, related or is a logical assignment to the position.

MAINDUTIES AND RESPONSIBILITIES

Core

Reviews plasma collection activities and donation records and determines if records comply with SOP and regulatory requirements and ensures corrective action(s) as needed.

· Responsible, in collaboration with the Center Manager, for overseeing all activities related to product quality, and ensuring product quality.

· Ensures production personnel follow compliance of all Center activities with cGMP, KEDPLASMA DCOP's and other Company standards and protocols to meet regulatory requirements of the FDA, EMEA, Customer Specifications, and other regulatory bodies, as required.

· Ensures plasma release and shipment(s) meet specifications and requirements as defined by customers and in DCOPs.

· Reviews and investigates final shipment release deviations including accurate labeling and documentation of shipment(s).

· Reviews and ensures written approval of all DCOPs prior to implementation and confirming DCOP compliance with all applicable statutory and regulatory requirements. Additionally, prior to the implementation of each DCOP, ensures:

1. Identification of personnel responsible for performing each procedure are documented.

2. Procedures for training are in place and certifying individuals identified.

3. Responsibilities of supervisors in charge of oversight of performance of all procedures are in place.

4. Methods for periodic proficiency testing are in place.

5. Methods for periodic competency evaluation of individuals performing each procedure are in place.

6. Methods for evaluating the performance of each procedure during QA audits occurs.

7. Record maintenance is consistent with requirements for recordkeeping.

8. Direct observations of performance of routine and quality control procedures including, as applicable, donor suitability, sample handling, processing, testing, labeling, and instrument preventive maintenance.

9. Monitoring, recording, and reporting of test results by reviewing work sheets, quality control records, preventive maintenance records, and other records and entries (both manual and automated).

10. Written tests to assess problem solving skills, knowledge of DCOPs, and theory; and assessment of performance using internal blind specimens and external proficiency test specimens.

11. Minimum acceptable scores, performance, and remedial measures are in place to correct inadequate performance on competency evaluations documented and retained in personnel records.

12. Evaluation summaries provide useful information to correct individual or group performance problems identified, as needed.

13. CLIA proficiency testing, complaint investigations, staff training and certifications are properly performed and documented.

14. Understanding of applicable state and federal regulations including industry and corporate policies are documented.

Managerial / Supervisory

· Manages and oversees direct reports.

· Disciplines and terminates employees following approved company guidelines.

· Establishes and communicates performance standards to meet or exceed standards.

· Coaches others for success and to meet established goals and / or standards.

· Recruits, interviews, hires, and trains employees, as needed.

· Oversees work assignments to include supporting and rearranging workload of direct reports.

· Provides constructive and timely performance evaluations including motivating and evaluating employees based on established performance standards.

· Promotes staff retention by creating an open, positive, and supportive work environment.

· Receives, investigates, and responds to employee grievances. Involves and obtains guidance from supervisor and human resources when needed.

General

Must be able to execute all terms and conditions set forth in the KEDPLASMA Employee Handbook, including, but not limited to:

· Work in a safety-conscious manner which ensures that safe work practices are used in order not to pose a risk to self or others in the workplace.

· Comply with company Global Code of Conduct and company's policies and procedures and all the applicable regulations.

· Maintain a dependable attendance record and adhere to standards of cleanliness, grooming, hygiene, and dress code.

· Attend and participate in scheduled training, educational classes, and meeting(s) in a timely manner as instructed by supervisor/manager.

· Cooperate with department personnel, as well as other center staff to ensure services can be adequately maintained to meet the needs of the donors.

· Meet with supervisor/manager on a regular basis to assist in identifying and correcting problem areas and/or improving services.

· Complete all assigned tasks in a timely manner as instructed by supervisor/manager.

· Adhere to work schedules in completing and performing assigned tasks.

· Promote KEDRION Values: Together as One; Care; Integrity; Sustainable Impact; and Courage.

· Create and maintain an atmosphere of warmth, personal interest, and positive emphasis, as well as a calm environment.

· Interact in a tactful, diplomatic, and humanistic manner with donors, visitors, and co-workers to provide a safe, efficient, and caring environment which ensures the self-respect, personal dignity, physical safety of each donor and center guest.

· Treat donors, visitors, and co-workers with courtesy, respect, and dignity.

· Perform any miscellaneous duties or work assignments, as required.

Primary Contacts

· Donors, employees, auditors, inspectors, vendors, corporate staff, and visitors.

REQUIREMENTS

Education, Qualifications & Experience

· Bachelor of Science (BS) degree in a related field (e.g., healthcare, Life Sciences) preferred, or an

equivalent combination of education and experience.

· Three to five-year experience in the plasma industry or in a biomedical field preferred.

· Minimum one-year experience in a regulated industry, ideally cGMP experience preferred.

· Basic computer skills and familiarity with data entry and recordkeeping systems preferred.

· Proficiency in Microsoft Office software applications preferred.

Physical Requirements

Work is primarily light in nature, with exerting up to 25lbs of force occasionally and/or a negligible amount of force frequently to lift, carry, push, pull or otherwise move objects. Use of fingers to type and / or enter numbers on keyboards, keypads, etc. along with grabbing object(s). Additionally includes, reaching, handling, talking, hearing, bending, stooping, and walking. Involves sitting, standing, and walking most of the time.

Working Conditions

· Primarily inside with well-lighted and well-ventilated areas.

· Exposure to Blood Borne Pathogens.

· Periodic exposure to an environment with a temperature of -40°C for short periods of time.

Travel

· Travel as needed to plasma collection centers and other KEDPLASMA/Kedrion locations, which includes overnight travel.

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status.