Grifols Shared Services North America, Inc Quality Associate II / III / Sr Quality Associate I 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/Sr. Quality Associate I

The selected candidate will provide routine technical support for various tasks (i.e. documentation, training, compliance, product release, scheduling, etc.), assignments, projects, etc. for a Quality Control (QC) business unit within QC System. Depending on level of hire he/she may be responsible for coordinating work assignments, training or supervising a small shift or group of employees and is a fully qualified professional who requires minimal supervision.

Responsibilities include but are not limited to:

Quality Associate II-

Primary responsibilities for 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.

Quality Associate III-

Primary responsibilities for 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.

Sr. Quality Associate I-

● Consults with management to develop and implement solutions for achieving quality related objectives.

● Assists in the effective deployment of divisional or departmental technical resources in pursuit of annual goals.

● Uses expertise to make independent decisions within defined areas of responsibility.

● Leads or participates on multi-disciplined project teams. Also advances technical project proposals to senior management, following through to successful completion.

● Collects and analyzes data

● Prepares, reviews, and in some cases approves SOP revisions, Change Control Requests, Incident Tracking System entries and investigation reports.

● Other duties as assigned or as specified in the "Additional Responsibilities" section below may apply.

The primary area of responsibility will be support of the QC Plasma Chemistry and Raw Materials laboratories.

As a member of the Quality Control Methods Development & Validation group, the incumbent will perform or assist in the following:

  1. Raw Material test method development, validation, transfer, and replacement

  2. Chemistry test method development, validation, transfer, and replacement

  3. Assay troubleshooting

  4. USP, EP, JP, and ICH test method validation status of test methods, and compliance issues related to Quality Control Laboratories.

  5. Any new product/project test method development and validation.

  6. Regulatory submission documents generation or review

• The incumbent will direct and implement validation studies for methods and prepare protocols and reports for such studies that are suitable for review by regulatory agencies.

• The incumbent will direct in the replacement or transfer of test methods for improving assay performance and providing laboratory efficiency.

• Documentation will include, but is not limited to, writing test procedures, test method validation protocol and reports, method development reports, and investigation reports.

• The incumbent must have hands on experience on the instruments such as: HPLC, FTIR, IC, AME, GC, CZE, UV, KF…to support Chemistry assays for the QC Plasma Chemistry and Raw Materials laboratories and must have hands on experience in test method development and validation.

• The incumbent must have hands on experience planning and carrying out assignments as well as author documents to define progress of project and lab works.

• The incumbent is expected to participate in the design of experiments and interpretation of data obtained in the course of an investigation under the direction of QCMD&V senior staff and to strive to provide creative solutions to problems that may arise during an investigation.

• Experience within a GMP environment will be an asset

• The individual's scientific area of expertise should provide a strong understanding of Chemistry methods used to test Plasma Derived Product and Raw Material samples.

• The incumbent must have hands on experience with instrument qualification, software validation, and spreadsheet development and validation.

• Experience with protein analysis, purification, and characterization will be considered a plus.

• The incumbent must have strong oral and written communication skills, with the ability to effectively communicate ideas to people with varying degrees of technical understanding is essential.

• Strong computer skills are preferred or required especially with MS Word and Excel.

Salary Grade: Quality Associate II-M06

Quality Associate III-M07

Sr. Quality Associate I-M08

Hours: Day Shift 8 Hours Mon - Fri

Requirements:

Quality Associate II- MS degree in a relevant discipline (i.e. Chemistry or related discipline) 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.

Quality Associate III- MS degree in a relevant discipline (i.e. Chemistry or related discipline) 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.

Sr. Quality Associate I- PHD in a Life Sciences degree with minimum of 2 years relevant experience. MS in a Life Sciences degree with minimum of 4 years relevant experience. BS in a Life Sciences degree with minimum of 6 years relevant experience, or equivalent combination of education and experience.

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/Veterans/Disabled

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: 73788

Type: Regular Full-Time

Job Category: Quality