Loading...

Analyst II, QC (Raw Materials)-2nd Shift

Location: 

Baltimore (Bayview), MD, US, 21224


 

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
The Analyst II, QC Laboratory Services performs inspection and release testing of raw materials and packaging components as per USP/EP compendial test methods and standard test methods. The Analyst II, QC Laboratory Services performs testing as required to support method verification/validation and material & supplier qualification. In addition, he/she writes studies and reports to support investigations, supplier qualifications, and validation/verification studies. This position furthermore will mentor junior staff. This is a 2nd shift role supporting the Bayview site.


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

• Inspections incoming raw materials and performs sampling for release testing.
• Coordinates testing and shipments of samples with contract testing laboratories.
• Perform identification, assay and limit testing of raw materials and packaging components to support manufacturing requirements.
• Well versed in a wide variety of analytical and compendial methodologies and techniques such as FTIR, pH measurement, refractometry, density/specific gravity measurement using density meter, UV-VIS, distillation, titrations, HPLC and GC.
• Document laboratory work consistent with GxP requirements.
• Maintain laboratory records and inventory for standards, reagents and laboratory supplies.
• Perform preventative and corrective maintenance on laboratory equipment.
• Maintain a clean and sanitary work area in accordance with standard laboratory practice and procedures.
• Make detailed observations, consistently analyzing and interpreting data.
• Work productively with other team members as well as on independent assignments; increased level of independence/productivity compared to Analyst I.
• Write clear and concise SOPs; adhere to all effective SOPs and safety requirements.
• Provide input on lab requirements and improvements.
• Communicate professionally, verbally and in writing, with collaborators and external departments.
• Train and provide assistance to junior staff.
• Use experience and knowledge to investigate in order to identify the root cause of complex problems.
• Execute development and validation studies and write protocols/reports; review and provide feedback.
• Independently move projects forward.
• Solve and clarify problems in collaboration with other departments.
• Execute tasks with a focus on departmental objectives.
• Guide project progression through appropriate decision making.
• Maintain current understanding of regulatory requirements.
• Perform tasks effectively with minimal supervision.


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
• University degree or technical diploma in chemistry, biology or related field of study.
• Minimum of 2 - 4 years directly related experience in a recognized professional or technical/scientific field.
• Experience in a pharmaceutical cGMP environment is an asset.
• Proficient in Microsoft Office - Word, Excel, PowerPoint.
• Comprehensive knowledge of pharmaceutical GLPs and GMPs.
• Comprehensive knowledge of laboratory techniques and safety precautions.
• WHMIS and chemical safety awareness.
• Knowledge of regulatory guidance.
• Ability to work in a fast-paced and highly regulated environment.
• Able to multi-task and adapt to changing priorities.
• Competent in laboratory safety and generally accepted lab practice, including maintaining adequate written laboratory records.
• Able to communicate and articulate information in both written and verbal forms.
• Strong organizational and interpersonal skills and the ability to work collaboratively with others.
• Able to interpret analytical data, reviewing a variety of identifiable factors.
• Proficient in complex procedures and problem solving.
• Able to provide training to peers in an effective manner.
• Strong leadership skills, independence and initiative.


IV.  PHYSICAL/MENTAL DEMANDS AND WORK ENVIRONMENT CHARACTERISTICS

 

 

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.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

  • Stand shoulder to shoulder no matter what
    • We combine our best thinking and communicate openly to support each other.
  • Break through thinking
    • We take smart risks, pursue innovation and challenge ourselves to constantly improve.
  • Own it always
    • Every person at Emergent is engaged and accountable for delivering on our commitments.
  • Compete where it counts
    • We set the right goals and respect each other as we conquer them together.


Nearest Major Market: Baltimore