Specialist I, QC Compliance
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 QC Compliance Specialist will be responsible for writing, reviewing, and tracking the completion of quality investigations, CAPAs, Change Controls, and other compliance records for the QC department. This position also serves as an expert resource for the team in review of quality records including QC logbooks, in-process, release, and stability testing as needed.
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
• Assists with execution of GMP documentation and review of testing as required to support product release, stability, and validation studies.
• Work with QC SMEs to draft and review LIR, OOS, and QC deviations investigations as needed; provides recommendations and helps implement corrective action plans to address deficiencies.
• Work with QC SMEs to draft and review QC CAPAs and Effectiveness Checks to eliminate recurring root causes.
• Work with QC SMEs to draft and review Change Controls and present them to the Change Control Board.
• Leads or coordinates complex projects with other departments and interacts with other department personnel to accomplish objectives as needed.
• Assesses compendial changes; leads change control for revision of existing assays and identifies need for development of new assays in accordance with internal processes and consistent with compendial and GxP requirements, as applicable.
• Provides review and feedback to developmental labs in support of analytical assay development, transfer and qualification/ validation studies to meet regulatory and ICH guidelines.
• Work with appropriate SMEs to ensures the reliability and accuracy of the computer databases, and paper files.
• Writes proposals and/or summary documents suitable for external distribution or for regulatory submission that collaborate data from multiple sources.
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.
MINIMUM EDUCATION, EXPERIENCE, SKILLS
• Bachelor’s degree in chemistry, biology or related field of study.
• Minimum of eight years directly related experience in the pharmaceutical/biopharmaceutical or related industry.
• Possess relevant experience and the ability to mentor, guide, and develop team members.
• Ability to lead teams and projects leveraging strong technical skills to set strategies and priorities, and drive results of program objectives.
• Strong technical writing capability; can transfer ideas into scientifically sound and efficient study protocols and reports.
• Proficient and professional communicator with excellent oral and written communication skills and a desire to work in a collaborative team environment.
• 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.
• Ability to handle multiple projects at a time and have a strong attention to detail while understanding the higher-level strategy.
• Proficient in complex procedures and highly technical 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, laboratory techniques, safety precautions, and regulatory/industry guidance.
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.