Specialist I, QC Improver

We go where others won’t, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect and enhance life.

JOB SUMMARY

This Specialist position is primarily responsible for highly technical level work supporting the Vaccine and CDMO Business unit. The Specialist is responsible for the writing of technical assessments, protocols, reports, quality systems documents as well as supporting regulatory compliance activities. The Specialist will also act as a technical liaison with external and international CMO and CRO partners. The role also includes responsibilities for the Regulatory Surveillance and Tracking and Trending programs.

ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

Method Development and Validation:
• Conduct method verification, development and validation. This includes analyzing and interpreting data, writing protocols and reports, investigating analytical problems and developing approaches to rectify those problems.
• Provides scientific review of protocols, reports, study design and standard operating procedures.
• Training for processes and new procedures.

Support QC Quality notifications management (Deviations, CAPA):
• Author and review laboratory investigations (LIR, OOSs/OOTs), provide SME support of root cause analysis, hypothesis studies and exploratory studies.
• Provide SME support in development and execution of corrective action / preventive action plans (CAPA).

Change Control/ Supplier Notifications / Material Qualification:
• Authoring and implementation of Quality Systems documents (Change Controls, CAPA, and supplier notifications)
• Participate in qualification process of new supplier and/or material.
• Initiate and assist in implementation of Change Control activities.
• Evaluate supplier technical data package, material protocol, write material qualification, qualification report, provide risk assessment for any change in material or supplier.

Regulatory support:
• Perform QC Micro and/ or Chemistry Regulatory surveillance and implementation of latest updates in keeping up with changing FDA, compendial and industry requirements.
• Participate in the preparation of regulatory submissions by providing technical content and expertise.
• Participate in the preparation of responses to regulatory requests by providing technical content expertise.

Tracking and Trending process:
• Participate in Tracking and Trending Process for monitoring Process and Quality Attributes at manufacturing site.
• Provide SME support in analyze the data, writing summary report and any change in monitoring process

Manufacturing and Delivery
• Department SME in multidisciplinary production/product development teams in new product manufacturing, and any changes in manufacturing process.
• Participate and provide assistance in process improvements and/or investigations (toxicological assessment, degradation estimation), cleaning validations or equipment qualification.

Manufacturing and Delivery of CDMO products:
• Department SME in multidisciplinary production/product development teams in new product manufacturing, and any changes in manufacturing.
• Participate and provide assistance in process improvements and/or investigations (toxicological assessment, degradation estimation), cleaning validations or equipment qualification.

Behavior/Cultural Responsibilities
• Ownership – Actively participate in self-development (SLII, IPMP)
• Accountability – Follow through on commitments
• Detail oriented – Able to complete required tasks and associated documentation with minimal error
• Adaptability – Maintain positive attitude in a changing work environment
Communication – Effectively communicate with all levels of manufacturing and support staff
• Participate in department / level meetings
• Escalate issues through the proper channels

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
• BS degree in Biology/Chemistry/Biochemistry/Microbiology or similar with 8 years’ experience; MS in Biology/Chemistry/Biochemistry/Microbiology with 2 or more years of experience; PhD in Biology/Chemistry/Biochemistry/Microbiology with 1 or more years of experience.
• 5+ years GMP laboratory experience in a pharmaceutical environment Validation of Microbial methods preferred.
• Experience with non-conformance, CAPA, and change control systems.
• Strong initiative, organization ability to work independently
• Capable to lead and/or participate within multidisciplinary teams within the site or in the organization
• Proficiency in MS Office products or comparable word-processing and spreadsheet applications is required.
• Capable to interpret statistical data
• Must have SOP, investigation, and project protocol writing skills
• Must have good verbal and written communication skills
• Previous experience with Laboratory Information Management Systems. Proficiency in MS Office products or comparable word-processing and spreadsheet skills are required
• Must have an understanding of US and EU cGMPs, GLP, and USP/EP

Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.

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 [Register to View] .

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.