Grifols Shared Services North America, Inc QA Associate II/III in Clayton, North Carolina

For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.

Quality Associate II / III

Summary:

The Quality Associate II provides routine technical support for various tasks (i.e. documentation, training, compliance, product release, scheduling, etc.), assignments, projects, etc. for a Quality Operations (QO) business unit within QO Supply Chain, Product Quality Management, or Compliance, Audits, and Systems. He/she may be responsible for coordinating work assignments, training or supervising a small shift or group of employees.

The Quality Associate III Demonstrates consistent application of technical knowledge and expertise. Executes assignments of medium complexity and develops solutions to defined problems for a Quality Operations (QO) business unit within QO Supply Chain, Product Quality Management, or Compliance, Audits, and Systems. He/she may be responsible for training or supervising a small shift or group of employees. He/she may be responsible for coordinating work assignments, training or supervising a small shift or group of employees. Fully qualified professional who requires minimal supervision.

Primary responsibilities for QA II role:

●Collects, reviews, and may analyze data.

●Makes decisions independently, but within a well-defined area.

●Addresses and resolves problems according to written procedure (i.e. SOP, etc.) or practice.

●May supervise or train employees.

●Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.

●Demonstrates high levels of value and integrity.

●Follows cGMP and department safety practices.

Additional Responsibilities for QA II role:

In addition to the duties described above the Quality Associate II may also perform the following duties based upon the business unit to which he/she is assigned:

Quality Operations Supply Chain:

Apply expertise in testing to develop, validate and troubleshoot analytical methods. Serve as SME for laboratory assays and act as a resource for laboratory staff. Perform investigations

and write reports. Author SOPs and other laboratory documents. Collaborate with production and PQM on projects, incident investigations, and annual product reviews. Evaluate data and perform statistical analysis for various projects. Serve as system administrator and SME for various laboratory information systems and applications as required

Quality Operations Compliance, Audits, and Systems:

Lead/participate in internal and external compliance audits. Lead/participate in supplier quality audits. Prepare, review, and/or approve validation and/or engineering documents. Anticipate/

lead internal compliance audits, audits of suppliers/contractors. Perform sampling/testing of raw materials. Collect and control stability program samples, review and analyze data, prepare and

review reports. Perform validation studies, prepare/review/approve validation documents. Participate in failure investigations, preparation/review of reports. Author, edit, and/or publish SOPs and

other documents. Collect, store, record samples and test results for follow-up and developmental stability program. Collect and test samples for incoming raw materials and/or materials clearance

testing. Review and approve reports and documentation prepared by other employees. Plan, schedule and execute routine and directed internal audits and follow-up on observations from previous

audits. Revise, negotiate, and complete Quality Agreements, Manufacturing Agreements and Confidentiality Agreements with suppliers, customers and distributors.

Quality Operations Product Quality Management:

Responsibilities may include roles (such as author, reviewer, administrator or coordinator) in all quality systems such as Change Control,

Discrepancy Management, Quarantine, Batch Release, LIMS, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering

projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality at business unit meetings, and project meetings.

Primary responsibilities for QA III role:

●Develops alternative solutions to problems, handles complex problems independently.

●Demonstrates strong technical expertise and ability to adapt to changing circumstances.

●Collects, reviews, and may analyze data.

●May supervise or train employees.

●Makes decisions with designated assignments that influence the goals of the department.

●Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.

●Demonstrates high levels of value and integrity.

●Follows cGMP and department safety practices.

Additional Responsibilities for QA III role:

In addition to the duties described above the Quality Associate III may also perform the following duties based upon the business unit to which he/she is assigned:

Quality Operations Supply Chain:

Apply expertise in testing to develop, validate and troubleshoot analytical methods. Serve as SME for laboratory assays and act as a resource for laboratory staff. Perform investigations

and write reports. Author SOPs and other laboratory documents. Collaborate with production and PQM on projects, incident investigations, and annual product reviews. Evaluate data and perform statistical analysis for various projects. Serve as system administrator and SME for various laboratory information systems and applications as required.

Quality Operations Compliance, Audits, and Systems:

Lead/participate in internal and external compliance audits. Lead/participate in supplier quality audits. Prepare, review, and/or approve validation and/or engineering documents. Anticipate/

lead internal compliance audits, audits of suppliers/contractors. Perform sampling/testing of raw materials. Collect and control stability program samples, review and analyze data, prepare and

review reports. Perform validation studies, prepare/review/approve validation documents. Participate in failure investigations, preparation/review of reports. Author, edit, and/or publish SOPs and

other documents. Collect, store, record samples and test results for follow-up and developmental stability program. Collect and test samples for incoming raw materials and/or materials clearance

testing. Review and approve reports and documentation prepared by other employees. Plan, schedule and execute routine and directed internal audits and follow-up on observations from previous

audits. Revise, negotiate, and complete Quality Agreements, Manufacturing Agreements and Confidentiality Agreements with suppliers, customers and distributors.

Quality Operations Product Quality Management:

Responsibilities may include roles (such as author, reviewer, administrator or coordinator) in all quality systems such as Change Control, Discrepancy Management, Quarantine, Batch Release, LIMS, Documentation, and Annual Product Reviews as well as provide Quality input for Validation projects, capital engineering projects, clinical studies, stability studies, ETPs, and Regulatory submissions. Responsible for representing Quality at business unit meetings, and project meetings.

Requirements:

QA II- MS degree in a relevant discipline (i.e. Biology, Microbiology, etc.) with minimal experience or a BA/BS degree in a relevant discipline and a minimum of 2 years of related experience, or equivalent combination of education and experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

QA III- MS degree in a relevant discipline (i.e. Biology, Microbiology, etc.) with a minimum of 2 years of related experience or a BA/BS degree in a relevant discipline and a minimum of 4 years of related experience, or equivalent combination of education and experience. Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

The applicant must have relevant experience with batch record review, QC testing review and the following computer systems: SAP, TrackWise, LIMS, Bioman, MODA, and excel. The applicant should be familiar with SAP transactions, performing queries in TrackWise, and querying for data in MODA. The applicant should have excellent attention to detail, the ability to prioritize the assigned workload, and to work independently.

SALARY GRADE: M06 / M07

Shift: 1 st Shift

Work is performed in an office and a laboratory/manufacturing environment or warehouse. Exposure to biological fluids with potential exposure to infectious organisms. Exposure to occasional extreme cold below 32* in production areas. Exposure to electrical office and laboratory equipment. Personal protective equipment required such as protective eyewear, garments and gloves. Work is performed sitting or standing for 2-4 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. Light to moderate lifting and carrying objects with a maximum lift of 35lbs. Occasionally walks, bends and twists neck and waist, may reach above or below shoulder height. Frequent foot movements. Color perception/discrimination and near vision correctable in one eye to 20/30 and to 20/100 in the other eye. Able to communicate complex information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken and written words and sentences. Performs tasks by following a set of written or oral instructions/procedures.

EEO Minorities/Women/Disabled/Veterans

This position is Employee Referral Bonus Eligible

Location: [[mfield6]] : [[cust_building]]

Learn more about Grifols at http://www.grifols.com/es/web/international/home

Req ID: 74126

Type: Regular Full-Time

Job Category: Quality