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Quality Control Analyst II

HKA Enterprises North Laurel, MD Full-Time
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Quality Analyst II

I: Job Summary

The Quality Analyst II is responsible for independent, QA oversight of each Quality Systems in support of commercial and clinical product manufacturing at the site. They serve as a system owner for one or more Quality System.

The Quality Analyst II will provide technical leadership and support of quality systems and plant compliance. This role will provide oversight to projects to maintain internal/external customer expectations. They exercise judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. They serve as a resource of technical knowledge for established processes. The Quality Analyst II applies expertise and regulatory knowledge to support change and risk management, including application of scientific and technical innovation. They identify risk and evaluate mitigation strategies to address such risk. They identify opportunities for improvement at the site using Six Sigma methodologies. Coaches employees through problems of diverse scope in which analysis of situations requires evaluation and interpretation of industry regulations. Supports junior level employees to ensure completion of assignments using established procedures and regulatory guidelines. Frequently interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across the company to gain alignment on sound quality decisions. Must be able to work independently with minimal supervision.

II: Essential Functions 


Provide QA oversite for incoming commercial and clinical projects, liaise between internal Global project team and external customers

Critically reviews various types of documentation to ensure completeness, accuracy, and compliance including but not limited to manufacturing records for batch and material release, specifications, validation protocols and summary reports, regulatory submissions, product complaints, annual product reviews, Quality Agreements, Supplier Notifications, Request For Proposals, SOPs, master plans, deviation investigations, CAPAs and change controls

Support department Operational Excellence Projects

Communicates on Department Manager’s behalf when needed

Communicates effectively with management project status, issues, and mitigations

Assumes responsibilities for assigned tasks including a subset of the activities listed herein

Product & Material Release

Independently review and perform disposition of raw materials, components, bulk drug substance, and final drug substance

Release raw materials using SAP system

Liaise with contract manufacturers responsible for filling, inspection, labeling, and packaging of product by providing Quality oversight for deviations, change controls, and other quality systems that may impact the company’s products

Assist with oversight and support of reference materials and retention programs

QA on the Floor

Support/execute QA on the Floor program

Support/execute revision and creation of Standard Operating Procedures in document management system

Support/review and approve executed Batch Record review

Support Batch/Cell Bank disposition

Support internal customers in manufacturing, QC, Engineering and Facilities, Validation, Supply Chain, Procurement and QA

Support QA oversite for incoming commercial and clinical projects

Support cross functional teams made up of employees at various experience levels and provide input as needed on Quality/compliance issues.

Initiate Quality Notifications (Deviations, CAPA’s and Change Controls)

Exercise judgment within defined site procedures to determine appropriate action for resolution of technical issues

Receive assignments in the form of objectives to help achieve department goals

Participate in company sponsored training

Support regulatory and client audits

Provide Quality input/support to investigations, CAPAs and changes

Support site inspection readiness strategy and activities

The above statements are intended to describe the general nature of work performed by those in this job.  It is not an exhaustive list of all duties, and other duties may be assigned.

III: Education, Experience & Skills

Bachelor’s Degree in Scientific, Engineering or related fields

A minimum of 2 years of cGMP Quality experience (technical, validation, quality control, or quality assurance)

Ability to work independently with minimal supervision

Prior experience with US, EU and Canadian pharmaceutical regulations, ISO standards

Knowledge and application of GMP principles, and working in an FDA regulated environment

Strong communication skills: oral/written and listening

Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability

Interpersonal skills: team building, consensus building, conflict resolution

Critical analytical skills, strong verbal and communication skills

Ability to work under pressure and analyze processes within scheduled timeframes

Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, and Visio.

Ability to travel (10%)

Recommended skills

Product Quality Assurance
Interpersonal Skills
Packaging And Labeling
Team Building
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