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Specialist II, QC Compliance

Employer
Emergent BioSolutions
Location
Baltimore, MD
Start date
Sep 1, 2023

View more

Discipline
Clinical, Clinical Medicine, Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioCapital

Job Details

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.

I: Job Summary 

The Specialist II, QC Lab Services leads or supports lab activities related to quality management systems, risk analysis, hazard analysis, and inspection/audits.  This position is expected to provide management-level support to these activites.  The position provides support for all administrative functions unrelated to personnel involving the Microbiology and Analytical Laboratories including department compliance related activities.  Responsibilities focus on support of new product transfer into QC, client/regulatory inspection CAPAs, change controls, risk assessments, HACCPs, deviations, and project management.  Hours may vary to meet business and training needs. 

This position will be expected to review and approve related documents for the department as designated and represent the department in a lead role in designated assignements.  This position will have no personnel management resonsibilities.   This position reports to the QC Sr. Manager of QC Compliance.  This position is 100% on site.  Typical hours are 8:00am – 4:30pm, Monday through Friday.  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 and support for audit/ inspections of labroatories.  
•    Assist the Laboratory Management with feasibility assessment of client projects and reports.
•    Suppport Quality control releated risk assessments and hazard analysis report writing and approval.
•    Lead and support lab related activies for quality systems, such as CAPAs, change controls, deviation writing/review and effectiveness checks to ensure timelines are met. 
•    Initiates or assists with change controls and follows them to closure for the laboratories.  
•    Author and execute CAPAs Master’s degree preferred client observation responses with the assistance of Laboratory Management.
•    Represent the QC Laboratory department at cross-functional meetings.  
•    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 review/approval of QC testing for new projects.
•    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 review/approve 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.

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
Education and Experience: A minimum of a B.S. in Chemistry, Microbiology or related scientific discipline with a minimum of 15 years’ experience.   Master’s degree preferred

Must have sound scientific background in analytical chemistry and/or microbiology and typical quality control applications.  Sound knowledge of the functions of a QC Laboratory operations. Strong written and oral communications skills.  Advanced skills and fluency in LIMS Systems, Adobe, Microsoft Word, Outlook and Excel.  Must have experience in quality control change management.  

Demonstrates knowledge and application of typical regulatory guidance such as cGMPs/GLPs, ICH, FDA, EMA, and CMC documents.   Demonstrates knowledge in Data Integrity principles.  Demonstrates knowledge of quality control regulatory requirements.  Expected to be familiar with CFR, USP, and EU regulatory requirements.  Demonstrates solid communication and presentation skills.  Demonstrates cross functional understanding and result-driven abilities. 

Must be highly organized, detail oriented, and able to manage multiple projects and work with cross-discipline personnel.  Must be capable of independent management of long-term projects.  Expected to make independent decisions for near-term goals.  Strong problem solving and root cause analysis skills.  Strong analytical and strategic thinking skills are expected.

 

VI.  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.

Company

Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter.

Stock Symbol: EBS

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Company info
Website
Phone
240-631-3200
Location
400 Professional Drive
Suite 400
Gaithersburg
Maryland
20879
United States

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