Specialist II, Quality Assurance - Military Veterans
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.
I. JOB SUMMARY
The QA Specialist II professional will be responsible for managing the quality Batch Record Review process to ensure timely completion of review, approval and closure, training of team members and management of quality binders. Responsible for Product and Raw Material Disposition process, to include coordination with QC for product specifications test results, coordination with Rockville Fill Finish site quality, 3rd party Diluent supplier and Supply Chain. In addition, the QA Specialist II will support the manager with the Complaint and APR programs at the Emergent Canton, MA site, manage the Right First Time (RFT) metrics, provide On-the-Floor support to manufacturing and a quality SME of SAP material master data. Manage and lead projects, own quality records (Deviation/CAPA/Change Control) and support additional work as required.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Review/Approve of Batch Records (including APS, Engineering and Development runs) and other related documentation.
• Disposition of Product and Raw Materials & components. Quality SME in SAP Master Data
• Manufacturing On-the-Floor support (Quality Oversight, logbook review, solve issues real time with operations personnel, etc.)
• Provide data for functional area metrics for APR and complaints among others with the objective to identify and improve system compliance and/or process challenges
• SOP generation, review and/or approval
• Own quality records (Deviation/CAPA/Change Control).
• Manage and support the Complaint program
• APR generation and approval
• Must be capable to work independently and strategically to ensure day¬ to-day activities are carried out in support of the business goals
• Lead or assist in continuous improvement projects as assigned interacts with senior leadership, direct manager, peers, internal customers, external clients and other cross functional peers across Emergent to gain alignment on sound quality decisions.
• Lead and support additional work as required.
The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.
III. MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelor’s Degree in Scientific or related fields
A minimum of seven (7) years of cGMP Quality experience
Product and Raw material disposition is a must
Well versed in SAP is a must
Batch Record review is a must
Strong Commercial manufacturing experience (Large Molecules) required
Expertise on change control, complaint management and Annual Product Review/Product Quality Review (APR/PQR) is a must
Experienced with US, EU pharmaceutical regulations, and ISO standards
Expert Knowledge and application of GMP principles
Excellent communication skills: oral, written and listening
Ability to influence without authority across cross-functional organization
IV. PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.
Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.
Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable 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.
Emergent BioSolutions is a global life sciences company dedicated to one simple mission—to protect and enhance life. We develop, manufacture, and deliver a portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us @emergentbiosolu and @life_at_emergent