Sr. Quality Associate I/Sr. Quality Associate II - QA Packaging

Grifols • Clayton, NC

14d • Onsite

About The Position

The incumbent will be assigned duties and responsibilities within Quality Assurance to support the QA Packaging Business Unit which provides Quality oversight. In this role the incumbent will interface with plant manufacturing and support groups to execute site quality systems. Specific duties may include serving as author, reviewer, administrator or coordinator for quality systems such as Change Control, Discrepancy Management (including deviations, Product Technical Complaints and CAPAs), Quarantine, Documentation, and providing Quality input for Validation projects, Regulatory submissions and audits. The incumbent will be responsible for representing Quality at project meetings. The incumbent is an established and technically competent professional who develops and provides solutions and is able to influence the direction of project/quality related objectives. The incumbent may participate on teams or projects of varying scope and is often called upon by peers for their expertise or guidance/ is recognized as an authority in multiple areas. The incumbent demonstrates consistent application of technical knowledge and expertise, executes assignments of medium to complex nature, developing solutions for defined technical problems. The employee may be responsible for training other employees and is a fully qualified professional who requires minimal supervision. The incumbent must have a strong knowledge of cGMPs, the ability to perform independently, and the ability to solve moderate technical problems. Knowledge of packaging processes is recommended. A proactive philosophy, attention to detail, and good human interaction skills are essential and must have been demonstrated in previous work. The incumbent should be able to prepare reports/presentations and be able to effectively communicate information to varying levels of management. The incumbent should be able to actively participate on teams of varying complexity. The incumbent must be a professional with moderate to high technical competency. Incumbent must have good to excellent judgement, and investigative, analytical, and organizational skills. Desired computer skills include Excel, Word and SAP. Experience in different aspects of pharmaceutical business is a plus.

Requirements

• M8: BS/BA degree preferably in a STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 5 years relevant experience, or equivalent combination of education and experience.
• M9: BS/BA degree preferably in STEM (Science, Technology, Engineering, and Mathematics) discipline with minimum of 6 years relevant experience, or equivalent combination of education and experience.
• Strong knowledge of cGMPs.
• Ability to perform independently.
• Ability to solve moderate technical problems.
• Proactive philosophy, attention to detail, and good human interaction skills.
• Good to excellent judgement, and investigative, analytical, and organizational skills.
• Excel, Word and SAP skills are desired.
• 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.
• 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.

Nice To Haves

• Knowledge of packaging processes is recommended.
• Experience in different aspects of pharmaceutical business is a plus.

Responsibilities

• Serve as author, reviewer, administrator or coordinator for quality systems such as Change Control, Discrepancy Management (including deviations, Product Technical Complaints and CAPAs), Quarantine, Documentation.
• Provide Quality input for Validation projects, Regulatory submissions and audits.
• Represent Quality at project meetings.
• Develop and provide solutions and influence the direction of project/quality related objectives.
• Participate on teams or projects of varying scope.
• Train other employees.
• Prepare reports/presentations.
• Effectively communicate information to varying levels of management.
• Actively participate on teams of varying complexity.

Benefits

• Equal employment opportunities to applicants and employees without regard to race; color; sex; gender identity; sexual orientation; religious practices and observances; national origin; pregnancy, childbirth, or related medical conditions; status as a protected veteran or spouse/family member of a protected veteran; or disability.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level