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 I, Quality Assurance (QA) is responsible for Quality oversight of processes in manufacturing/production and/or release laboratories. This position interacts with Manufacturing, Quality Control, Production Planning, Emergent partners and Auditors/Inspectors to ensure required inputs for the manufacturing process meet cGMP requirements within established timelines.
• Provide quality “on the floor” support and oversight to assist in resolving manufacturing issues with oversight from QA management
• Follows written instructions in the routine review of laboratory and production records in accordance with Emergent standard operating procedures (SOPs) and good documentation practices (GDP)
• Reviews routine work orders, return to service, and other documentation to ensure that equipment and utilities are fit for use
• Perform label control processes such as counting, verification, issuance, receipt and reconciliation of components, and verifying area clearances
• Supports minor Non-conformance investigations which may contain basic root cause analysis
• Uses existing procedures to solve routine or standard problems
• Recognizes errors in records and resolves them in a timely manner
• QA approver on minor/administrative SOP revisions
• Supports basic improvement projects
• Works within technical guidelines and direction to achieve objectives and meet deadlines.
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
• BA/BS (in an applied science preferred) or equivalent work experience.
• 1-3 years of experience working in an FDA regulated industry
• Experience with quality assurance preferred
• Basic conceptual knowledge and practices associated with Document Review and Product Disposition
• Gowning for BSL-2 and BSL-3 and Aseptic environments preferred
• Candidate must exhibit strong interpersonal and communication skills, strong oral and written communication skills
• Ability to make sound decisions regarding compliance-related issues with supervision
• High level of personal/departmental accountability and responsibility.
• Familiarity with pharmaceutical industry guidance (ICH, CFR 21.210-211, USP)
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 40 lbs, and pull 40 lbs. Use phone, fax, copier, and computer. Organize/coordinate/analyze/interpret data, read common measurements, problem solve, make decisions, supervise, plan, communicate, prepare written communications, and prepare transaction documents. Some occasional work in cold temperatures, and restricted access laboratories (BSL2-3), and with exposure to animals, animal areas, or equipment used in animal areas.
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.