Analyst II, Quality Assurance
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POST DATE 11/20/2019
END DATE 2/13/2020
JOB DESCRIPTIONThose 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.
I: Job Summary
The QA Analyst II is responsible for performing duties related to raw materials review and release for the CGMP operation of Emergent BioSolutions in Baltimore (Camden Facility). Our QA Department provides expertise in problem solving and process improvements. The QA Analyst will interact with all departments to provide guidance necessary to maintain and improve CGMP compliance at the company.
Key Duties will include:
* Perform critical reviews of Material documentation submitted for QA disposition by exercising judgment within defined procedures and regulations
* Perform activities associated with the Active Pharmaceutical Ingredient (e.g. receipt, inspection and document review)
* Perform AQL Inspection of Printed Materials
* Review and edit Material Specifications
* Review and revise Standard Operating Procedures as it pertains to Material Disposition and Material Specifications
* Provide support in Deviations, CAPAs and Change Controls as it pertains to the disposition of Materials and Material Specifications.
* Assist in maintaining Quality metrics
* Respond to various interdepartmental requests. Answer questions and provides feedback to ensure Quality and departmental objectives are met.
* Scanning and ancillary filling
* Keep management informed of concerns/issues/successes
* Within area of responsibility, understand and comply with all safety and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs
* Identify opportunities for improvement within scope of work
* Participate in Lean Six Sigma activities
* Perform other duties assigned to enable organizational and quality objectives to be met
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
* BS or MS degree in Chemistry/Biology or related discipline with 2-4 years Quality Assurance experience preferred.
* Must have strong attention to detail.
* Ability to manage multiple priorities and tasks in a dynamic environment.
* Excellent written, verbal and interpersonal skills with the ability to effectively interact with cross-functional teams.
* Ability to exercise judgment to determine appropriate corrective actions.
* Ability to exercise judgment for defined practices and policies in selecting methods and techniques for obtaining solutions.
* Ability to work in a team environment.
* Working knowledge with SAP and Microsoft Office Suite programs such as Word, Excel, and Access.
* Knowledge of Pharmaceutical CGMP Regulations.
IV: Physical/Mental Requirements
* Type/keyboard, visual acuity, stand, walk, sit, twist/turn, climb stairs, bend, squat/kneel, lift/carry up to 25 lbs, and pull up to 100 lbs. Organize/coordinate, analyze/interpret, problem solve, make decisions, plan, communicate, prepare written communications, and prepare transaction documents.
* A percentage of work time is spent in a warehouse where temperatures are cool and noise level can be moderate to high.
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.
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.