Lead Associate, Manufacturing (MA III)
Company: Emergent BioSolutions Inc
Posted on: February 22, 2021
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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 primary role of this position is
to provide technical support for all fill finish operations with
strict adherence to cGMP compliance. The candidate will also
provide guidance for all on-floor activities including aseptic fill
operations, visual inspection, labeling, and packaging of bulk
product with minimal supervision. This position requires
proficiency in aseptic technique, and deliberate movements inside
various isolators. The candidate for this position will be working
in close association with Technical Operations, Quality Assurance,
Quality Control, and Material Management to overcome challenges in
meeting the production schedule. II. ESSENTIAL FUNCTIONS
Reasonable accommodations will be made to enable individuals with
disabilities to perform the essential functions. --- Execute daily
tasks such as washing and sterilizing vials and filling components
for use in production operations. Perform area clearance on
equipment and rooms that involve cleaning, and integrity testing
--- Perform Aseptic filling operations and dynamic
monitoring/sampling inside various isolators.
--- Adhere to Standard Operating Procedures (SOP), Good
Documentation Practices (GDP), and current Good Manufacturing
--- Author and revise batch records and SOPs.
--- Perform routine reviews on executed batch records and
--- Initiate deviations, CAPAs, and Change Controls.
--- Generates Purchase requisitions for consumables items within
the MFG department.
--- Assist in activities related to other onsite departments such
as the execution of validation protocols.
--- Comply with all applicable health, safety and environmental
policies promoting a safe workplace to prevent or reduce
--- Perform tasks under minimal supervision, and within tight time
lines to meet production schedule.
--- Report any unexpected observations and suggest possible
explanation and resolution. 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
--- BS/BA in Biology, Chemistry, or related discipline
--- 3-5 years' experience in a GMP facility or High School Diploma
and at least 5 years' experience in a GMP facility.
--- Good interpersonal skills and attention to detail.
--- Analytical, organized, self-motivated, and good at
--- Previous experience working with aseptic technique and good
documentation practices is required.
--- Must be able to follow cGMP regulations during operations
including adherence to written procedure and contemporaneous
--- Must be able to communicate effectively with management and
--- Must be able to record data accurately and legibly.
--- Demonstrated mechanical aptitude and have manual
--- Ability to perform in a team setting in a controlled
environment for long periods of time. 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
-- 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
- 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
Keywords: Emergent BioSolutions Inc, Rockville , Lead Associate, Manufacturing (MA III), Other , Rockville, Maryland
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