We go where others wont, 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.

I: JOB SUMMARY

The Specialist II, QC Lab Services provides support for all administrative functions unrelated to personnel involving the Microbiology and Analytical Laboratories,and supports activities across all shifts. Responsibilities focus on support of new product transfer into QC, client/regulatory inspection CAPAs, change controls, and project management. Hours may vary to meet business and training needs.

II: ESSENTIAL FUNCTIONS

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

Direct support of Laboratory Management for non-personnel-related tasks.
Assist the Laboratory Management with feasibility assessment of client projects and reports.
Review/Approve Validation and MS&T reports for laboratory services.
Writes/Approves deviations and assists with testing plans as needed.
Authors/Reviews/Approves new QC documents such as specifications and batch records for new project introduction from MS/T.
SME for transfer projects and provides direct leadership with scheduling, executing and reviewpproval of QC testing for new projects.
Author and execute CAPAs and client observation responses with the assistance of Laboratory Management.
Initiates change controls and follows them to closure for the laboratories.
Author raw material specifications and/or approves them for the laboratories.
Assists with biennial reviews of SOPs, Specifications, and Test Methods.
Authors SOPs and Test Methods as needed.
Reviews batch records (engineering, media fills, master production control records) for the laboratories.
Assist or perform client or regulatory tours of the laboratories.
Assist or author EM and Utility reports or author the reports.
Author and reviewpprove OOS and/or OOL investigations and testing plans as needed.
Take lead or assist in CAPEX projects for the laboratories.
Assist the laboratory personnel with setting outside contractors to come and perform preventative maintenance on various equipment.
Reviews/Approves raw data for the laboratories.
Assist and participate in LIMS discussions and training as it pertains to the laboratory.
Assist with sample delivery/receipt in the QC Labs, as necessary
Assist with the validation of system improvements (drafting user requirements, PQ protocols, and execution of protocols).
Provide depth and breadth of expertise in scientific and technical support on validation of methods that will be transferred to the Quality Control routine testing group.
Applies in-depth skill and broad knowledge of business to address complex problems and non-standard situations.
Review/Approve developmental/qualification/validation protocols.
Design and/or conduct training sessions for new protocols and procedures.
Assess the compliance status of current test methods/equipment, coordinate and execute testing to ensure various methods/equipment are meeting current industry standards
Conduct training sessions for new protocol and standard operating procedures, mentoring Laboratory Technicians, Assistant and Associate Scientists to develop laboratory core competencies
Represent the QC Laboratory department at cross-functional meetings.

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: MINIMUM EDUCATION, EXPERIENCE, SKILLS

Education:
Bachelors degree required, Masters degree preferred.

Experience:
Minimum 10 years of directly work experience.
Proven leadership and independent project management accomplishments.
Experience with method development or equivalent preferred.
Extensive technical expertise in analytical (chemistry) instrumentation and methods, including HPLC and GC in the Pharmaceutical industry.
Sound knowledge of the functions of a QC Laboratory operations and proficiency in GMPs in a FDA regulated manufacturing facility that include CFR Part 11 and Good Automated Manufacturing Practice (GAMP) guide (5).

Skills:
- Strong written and oral communications skills.
- High level of motivation and independence.
- Advanced skills and fluency in LIMS Systems, Adobe, Microsoft Word, Outlook and Excel.
- Strong analytical, troubleshooting, and problem solving abilities.
- Ability to work independently and in teams.

IV: PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

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 Privacy Policy<> .

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.