Specialist I, QC (Oxon Hill)
Compensation: $153,080.00 - $153,080.00 /year *
Employment Type: Full-Time
Industry: Scientific Research
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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
Supervision and oversight of raw material and component program. This includes scheduling and execution of raw material and component inspection, testing, and disposition to support manufacturing schedules. In addition, this role is responsible for the scheduling and execution of non-routine method qualification studies, reagent control, and raw material and component specification management activities. II: Responsibilites
- Responsible for scheduling, execution and quality documentation for the inspection, testing, and disposition of raw materials and components. Provides support for event investigations
- Responsible for the development and lifecycle management of raw material and component specifications.
- Responsible for scheduling and execution of test data review in a timely manner
- Responsible for ensuring laboratory equipment is maintained in a qualified and calibrated state and suitable compendial and non-compendial standards inventory is maintained to support material testing
- Ensure that lab activities are conducted according to safety guidelines, policies and legislation.
- Maintain quality and quantity of departmental work through initial and continued training and oversight of lab staff; propose additional or customized training to lab management according to need.
- Perform administrative duties such as approval of time documentation.
- Responsible for professional development, goal setting and performance review of lab staff
- Provide technical and scientific assistance/expertise as required to clarify and troubleshoot scientific challenges internally or in collaboration with other departments.
- Provide information in support of department budget. Contribute to departmental strategy and provide input on lab requirements and improvements.
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
IV: Physical/Mental Requirements
- University degree in chemistry, biology or related field of study.
- Minimum of five years directly related experience in a recognized professional or technical/scientific field, with experience in a leadership or supervisory role.
- Experience in an operating in pharmaceutical cGMP environment is required.
- Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
- Proficient and professional communicator, verbally and in writing.
- Demonstrated technical competence; can analyze data and interpret results to make scientifically valid conclusions.
- Strong organizational and interpersonal skills and the ability to work collaboratively with others.
- Proficient in complex procedures and problem solving.
- Strong commitment to teamwork, proven leadership skills, independence and initiative.
- Proficient in Microsoft Office - Word, Excel, PowerPoint
- Comprehensive knowledge of pharmaceutical GLPs and GMPs
- Comprehensive knowledge of laboratory techniques and safety precautions
- Experience with LIMS and SAP software applications is desired.
Type/keyboard, visual acuity, good eye/hand coordination, stand, walk, sit, twist/turn, reach outward, reach above shoulder, hand dexterity, bend, squat/kneel, sense of feel, sense of hearing, lift/carry 25 lbs, and pull 50 lbs. Use phone, copier, and computer. Use hand tools. Organize/coordinate, analyze/interpret, calibrate precise measurements, problem solve, make decisions, plan, communicate, prepare written communications, and prepare transaction documents. Restricted access to laboratory, in contact with Select Agents.
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.
Associated topics: diet, dietetic, drug discovery, healthcare, histologist, nutrition, patient, pharmacology, pharmacometrics, physiologist
* The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.
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