Analyst II, 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.
I. JOB SUMMARY
Individual will ensure deviations/CAPAs/CCs are timely addressed and closed relating to manufacturing/technical operations/quality control for the Fill and Finish Facility. Work closely with department subject matter experts (SMEs) to obtain pertinent information necessary to write/close deviations, providing expertise on necessary preventive measures, and to ensure site deviation metrics are in a controlled state. Individual will be the SME for defending relevant deviations in GMP audits (internal and external). Individual will participate and coordinate efforts for continuous improvement in deviation reduction and manufacturing operations for the site.
II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.
1. Author and resolve Deviations, Change Controls, CAPAs and additional documents to support production needs and meet product release requirements.
o Deviations – investigate deviations from all departments, perform thorough product impact analysis, utilize root cause analysis tools and work cross functionally to implement effective CAPAs. Interview personnel involved to determine true root cause, work closely with QA to close deviations prior to deadlines, organize and manage investigational team meetings. Communicate across multiple groups and levels to obtain consensus to facilitate deviation closure and CAPA implementation.
o CAPA/CC– Write CAPAs & CCs to meet production release requirements, support continuous improvement efforts and operational optimization. Identify appropriate CAPA/CC implementation plan and/or effectiveness checks.
o Additional Documents - Collaborate with area SMEs to write, review, revise and/or prepare manufacturing documents (BPRs, RPTs, SOPs, SWIs, etc.) in accordance with cGMPs and regulatory guidelines.
2. Independently analyze complex issues using risk appropriate decision making.
3. Demonstrate technical writing ability; capable of interpreting and citing specific procedures as it applies to investigation decision making and timely closure.
4. Initiate tracking and follow up of more complex issues stemming from deviation investigations.
5. Assist in the continuous reduction in generation of deviations by helping to implement effective preventative actions.
6. Identification and facilitation of interdepartmental continuous process improvements.
Requires vaccination against different viruses including Vaccinia virus.
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 Science and/or related field
• Minimum of 1-3 years of technical writing experience in the pharmaceutical/biotechnology discipline.
• Expertly write technical deviations relating to manufacturing process and review documents with the following skills:
o Thorough understanding of the biopharmaceutical manufacturing process, current Good Manufacturing Practices (cGMPs), CAPA, CC and regulatory guidelines.
o Highly organized individual with strong attention to detail and great technical writing ability
o Good analysis, troubleshooting, investigation and communication skills, both written and verbal
o Working knowledge of root cause analysis tools and continuous improvement techniques
o Ability to put complex thoughts and issues into writing in such a manner that an educated, but uninformed reader can understand and make decisions based on the written investigation report
o Ability to manage time and priorities effectively
o Ability to interface with others effectively at various levels in multiple departments, including customers
o Ability to work well independently and with minimum or no supervision and identify problematic deviations upfront
o High level of computer literacy, including MS Word and Excel
o Ability to work extended and flexible hours (including weekends) when needed
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.