Specialist I, Quality Assurance CW
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 Specialist I, QA Raw Materials is responsible for performing duties related to raw materials review and release for the CGMP operation of Emergent BioSolutions in Baltimore (Maryland Central Warehouse (MDCW) Facility). Our QA Department provides expertise in problem solving and process improvements. The QA Specialist will interact with all departments to provide guidance necessary to maintain and improve CGMP compliance at the company.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
Key Duties will include:
• Author, review and approve Material Specifications
• Assist with Harmonization of Material Specifications across multiple site operations for support of a centralized warehouse
• Act as a QA approver for Quality Master Data for materials in ERP system
• Perform receipt inspection and critical reviews of Material documentation submitted for QA disposition by exercising judgment within defined procedures and regulations
• Author, review and approve Standard Operating Procedures as it pertains to Material Disposition and Material Specifications
• Write deviations and provide support of CAPAs and Change Controls as it pertains to the disposition of Materials and Material Specifications.
• Track and trend raw material release data for monthly Quality metrics.
• Respond to various interdepartmental requests. Answer questions and provide feedback to ensure Quality and departmental objectives are met.
• 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 and lead opportunities for process improvements within scope of work
• Participate in Lean Six Sigma activities
• Perform other duties assigned to enable organizational and quality objectives to be met
This will be a primarily a day shift role (8:00 a.m. to 5:00 p.m.) Monday thru Friday position. Overtime and weekend work required as needed based on manufacturing needs.
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
BS or BA degree in Chemistry/Biology or related discipline with 5-10 years of GMP experience 3 years of QA experience preferred.
• Must have strong attention to detail.
• Ability to manage multiple priorities and tasks in a dynamic environment.
• Excellent written and verbal skills.
• Working knowledge of SAP (ERP System) and Microsoft Office Suite programs such as Word, Excel, and Access.
• 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.
• Proficient knowledge of CGMP and relative Pharmacopeia.
• Coordinate multiple tasks simultaneously.
• Understand and respond to a diverse population.
• Ability to make sound decisions regarding compliance-related issues with minimal supervision.
• Strong leadership skills; high level of personal/departmental accountability and responsibility.
• Minimum of one year in a FDA regulated industry.
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.