I: JOB SUMMARY
The Analyst II, Document Control is responsible for identifying risk and evaluate deficiencies while working with internal departments to appropriately remedy them. They work with the Quality Assurance Training Department to facilitate internal training on quality assurance requirements, processes, and procedures. They must show initiative with helping the Document Control Team and internal customer to improve processes and maintain cGXP compliance.
II: ESSENTAIL FUNCTIONS
- Critically review and approve various types of documentation to ensure completeness, accuracy, and compliance including, but not limited to, manufacturing records and Quality Control laboratory data for batch and material releases, specifications, SOPs, validation protocols and summary reports, master plans, deviation investigations, CAPAs, and change controls
- Interact with a wide range of internal customers as well as outside agencies and clients
- Resolves a wide range of issues in creative ways. Defines appropriate actions and requirements for resolution of issues
- Demonstrate good judgement in selecting method and techniques for obtaining solutions
- Network with senior internal and external personnel in own area of expertise
- Communicates effectively with management project status, issues, and mitigations
- Assumes responsibilities for assigned tasks including a subset of the activities listed herein
- Plan, schedule, and conduct internal and external (supplier) quality system audits per audit schedule. This includes a review of prior internal audits and regulatory inspections, reviewing procedures, processes, and activities in creating the audit plan
- Lead or participate in inspection readiness plans and activities and serve as subject matter expert in quality systems
- Conduct regulatory surveillance to maintain current regulatory expectations and devise and provide GXP training to the facility
- Independently review and perform disposition of raw materials, components, bulk drug substance, and final drug substance
- Liaise with contract manufacturers responsible for filling, inspection, labeling, and packaging of product by providing Quality oversight for deviations, change controls, and other quality systems that may impact EMOB’s products
- Assist with the oversight of Support the reference and retention programs
- Maintain Emergent’s Quality Systems including, but not limited to, Deviations, CAPAs, Change Control, and Management Review in support of manufacturing operations
- Lead or participate in cross-functional teams to address facility issues using methodical problem-solving tools in analyzing the issues, determination of root cause, identification of appropriate corrective and preventive actions, and assessment of impact to product
- Prepare functional and Management Review metrics for identification of negative trends. Conduct analysis of identified negative trends and propose/implement necessary corrections to address and present to Management team
- Serve as primary liaison between EDMS Global Administrator and Baltimore’s EDMS users to maintain EDMS functionality and perform administrative activities for the applicable software
- Serve as technical expert to assist and provide support to end users. Provides EMDS users with Level appropriate training as required and maintains EDMS training materials
- Ensure document lifecycle from generation of document to archival
- Assist in managing New Employee Orientation program
- Assist in maintaining Training Program including identification of training needs for the facility and maintenance of Site training curricula
- Serve as a liaison between LMS Global Administrator and Baltimore’s LMS users to maintain LMS functionality and perform administrative activities for the applicable software
III: MINIMUM EDUCATION, EXPERIENCE, SKILLS
Bachelor’s Degree in Scientific or related fields
A minimum of three 3 years of cGMP Quality experience
Quality Auditor, Six Sigma, or equivalent certification/education preferred
Prior experience with US, EU and Canadian pharmaceutical regulations, ISO standards
Knowledge and application of GMP principles, and working in an FDA regulated environment
Strong communication skills: oral/written and listening
Strong facilitation skills
Experienced in developing and delivering technical/classroom training
Personal Competencies: Self-awareness, Integrity, Judgment, Vision, and Adaptability
Interpersonal skills: team building, consensus building, conflict resolution
Critical analytical skills, strong verbal and communication skills
Ability to work under pressure and analyze processes within scheduled timeframes
Ability to work independently in conducting quality system and process audits.
Proficiency using PC software programs, including PowerPoint, Excel, Word, Outlook, Internet Explorer, Access, and Visio.
Excellent presentation skills, including written and verbal communication skills
Ability to travel (10%)
IV: PHYSICAL /MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS
Type/keyboard, visual acuity, stand, walk, sit, squat/kneel, sense of hearing, and lift/carry 15 lbs. Use phone, fax, copier and computer. Organize/coordinate, analyze/interpret, problem solve, make decisions, supervise, plan, communicate and prepare written communications.
Successful applicants for this position must be fully vaccinated against COVID-19 as a condition of employment. Individuals with qualifying medical issues or sincerely held religious beliefs or practices that may prevent them from getting the vaccine may request an exemption from the vaccine requirement.
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.
Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our .
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.