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Analyst III, Quality Assurance

Company: Emergent BioSolutions
Location: Lansing
Posted on: January 16, 2020

Job Description:

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life.

The Analyst III, Quality Assurance position is a quality professional responsible for QA oversight of manufacturing/production processes and Quality Control laboratories.

The Analyst III is responsible for QA oversight of an area of the production process, and management and execution of Quality System work. The Analyst III also serves as a subject matter expert in Emergent quality systems and may represent Emergent during on-site inspections. This position frequently interacts with department managers, internal customers, and other cross functional peers to gain alignment and make quality related decisions.

Responsibilities

* Provide quality on the floor support and oversight to help resolve manufacturing issues independently. Performs audits of the manufacturing facilities and laboratories to ensure compliance with internal Emergent procedures and cGMPs.
* Reviews Product Manufacturing and Testing records to ensure product specification and process requirements are consistently met in accordance with Emergent standard operating procedures
* Prepares records of product manufacturing to support product release. Release intermediate materials for further processing.
* Ensure documentation supporting product manufacturing and testing follows good documentation practices (GDP) and principles of data integrity.
* Reviews work orders, equipment return to service, and other documentation to ensure that equipment and utilities are fit for use
* Perform labeling and packaging control processes such as counting, verification, issuance, receipt and reconciliation of components, and verifying area clearances
* Supports Major and Critical Non-conformance investigations inclusive of a detailed root cause analysis and sufficient corrective actions
* Serves as a decision-maker on major procedure changes, deviations, corrective and preventive actions, change control and site projects.
* Writes and reviews moderately complex technical documents including validation, testing, and stability data, for completeness accuracy.
* Act as a Quality Assurance subject matter expert for an integrated process team
* Support internal and external inspections as a subject matter expert
* Responds to customer inquiries and complaints.

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.

Education, Experience & Skills

* BS (in an applied science preferred) or equivalent work experience.
* 6-8 years of experience working in an FDA regulated industry with at least 3 years of experience in quality assurance
* Experience with aseptic processes, clean room gowning, and Pharmaceutical quality system work preferred
* Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills
* Ability to make sound decisions regarding moderate to high complexity compliance-related issues.
* High level of personal/departmental accountability and responsibility.
* Strong familiarity with pharmaceutical industry guidance's (ICH, CFR 21.210-211, USP)
Physical/Mental Requirements

Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, climb, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, sense of smell, lift/carry 25lbs, and pull 25lbs. Use phone, copier, computer, copier, and hand tools. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem-solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Work around noise above conversation level, in hot/cold temperatures, where ventilation is needed, in multiple locations, and with restricted access to laboratory.

Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.

Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy .

Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Keywords: Emergent BioSolutions, Lansing , Analyst III, Quality Assurance, Professions , Lansing, Michigan

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