QC Scientist II-Cell Based Assays
Posted on: May 16, 2022
The statements below reflect the general responsibilities and
requirements of the identified position but may not describe all
the work requirements that may be inherent in the job. Job
Summary:Working as part of the QC Laboratory Operations Group, the
QC Scientist routinely manages a number of assays pertaining to
common techniques. Typically, the QC Scientist will be responsible
for single projects (for one or several related techniques), may be
part of a larger cross-sectional team leading small to medium
multi-technique projects (as a molecule lead), - or be part of a
larger cross-sectional project working in conjunction with a more
experienced QC Scientist - or Lead Scientist.Project requirements
may include, but are not limited to; assay transfer, validation,
sample analysis, batch/release testing, and stability studies. They
will write protocols and reports, prepare and review analytical
procedures, and be accountable for the approval and integrity of
data and associated quality documentation.The QC Scientist has
knowledge within a relevant field and is able to troubleshoot
techniques in the area of their expertise. The management and
approval of assay data by the QC Scientist forms a large area of
responsibility for GMP projects.They may also be required to act as
a Study Director or Principal Investigator for GLP projects, or
Responsible Scientist for GCP projects. The QC Scientist is
therefore required to adapt to changing regulatory requirements,
depending on project types. -In this role, the QC Scientist will
provide internal customers with a central scientific point of
contact for techniques within their area of expertise, or for
external Clients where the QC Scientist is not the molecule lead.
The individual is accountable for effective communication either
directly with the Client or via the molecule lead to ensure that
Client requirements and project deliverables are met. This includes
discussion with the Project Management Office (PMO), molecule lead
if applicable, and communication with QC Section Managers, as well
as other scientific and analytical staff. The QC Scientist has
scientific oversight of relevant techniques in order to ensure the
successful initiation, planning, execution, monitoring and
completion of projects.The QC Scientist is required to have good
working knowledge of the GMP/GLP/GCP and regulatory guidelines as
they ensure that projects are carried out to the required
standards, and that work is conducted in compliance with applicable
regulatory requirements.The QC Scientist will be responsible for
overseeing the work of other QC Scientists where appropriate. They
will be expected to train, coach and mentor members of the team and
across functions as required. The individual will work with more
experienced QC Scientists or molecule leads to identify and
communicate scientific and regulatory developments within their
field of expertise, to include QA, management, Lead Scientists, QC
Scientists and Laboratory Analysts. The QC Scientist may represent
Covance internally or externally by preparing and/or giving
presentations, writing or supporting the preparation of scientific
papers and/or posters, in order to communicate the work of Covance
QC laboratory operations. The QC Scientist will be required to
perform lab work as required, and provide support with regards to
general laboratory operations and processes, leading by example to
members of the QC operations team.The post holder will adhere to
the BiopharmCMC SOPs and will be responsible for completion of all
relevant documentation. People Responsibilities: The position may
be associated with line management responsibilities. Additionally,
project specific supervision will be required as appropriate.
Essential Job Duties: - Initiation
- In support of project initiation and proposals, participate in
conference calls and Client visits as required.Planning
- Perform and review gap analysis for Client methods being
transferred in your area of expertise.
- Knowledge of the client requirements and plan accordingly to
meet Client deadlines.
- Ensure Health and Safety information (including GMO risk
assessments if applicable) are in place and are readily
- Participate in and/or conduct project meetings.
- Attend client conference calls and meetings for specific
technical requirements arising during projects.
- Work across all operational sections and other
departments/sub-contractors associated with a specific project to
achieve overall milestones.
- Prepare and approve project protocols and amendments. Ensure
that the required regulatory, scientific and client requirements
- Perform content review of standard protocols for all assay
types e.g. development, validation, sample analysis, release
- Ensure assays are performed in accordance with the protocol,
Client requirements and Covance Standard Operating Procedures
- Complete test schedule (where appropriate).
- Coordinate or facilitate the scheduling or management of lab
work, where necessary.
- Where appropriate, write or manage validated Analytical
Procedures (AP), Client Methods, Working Documents (WD) and/or
Workbooks, and competently review these documents.
- Perform lab work as required.
- Review and approval of regulatory (GMP/GLP/GCP) data.
- Write (where appropriate) assay based quality documents -
Quality Events, Risk Assessments, CAPAs, Change Controls, Out of
- Perform tracking/trending and subsequent interpretation of
assays and feedback to Operations and Clients as appropriate. When
acting as molecule lead on more complex study types, review
tracking and trending and feedback any potential issues to
Operations and Client as appropriate.
- Identify and communicate adverse events to management and seek
and find solutions to problems.
- Ability to problem solve unexpected analytical events within
projects/assays, and issues within the wider group.
- Prepare project reports and Certificates of Analysis (CofA),
and approve these documents where necessary.
- Accountable for QA and Client comments on Protocols and Reports
- Ability to make decisions on assay results/data.
- Write and approve assay investigation reports.
- Adhere to Quality Agreements and be aware of QC Scientist and
Covance responsibilities. Monitoring and Controlling
- Be aware of the study or assay status at all times and
anticipate issues which may affect, quality, time lines etc. To be
responsible for communication of the issues to all parties
internally and to take appropriate action to resolve.Closing
- Ensure all studies are archived in accordance with the current
- Manage batch testing, release testing, sample analysis,
stability, assay development, establishment and/or
- Good working knowledge of relevant scientific and GMP/GLP/GCP
- Act as a Subject Matter Expert (SME) within a QC Section.
- Knowledge of standard and non-standard study designs and the
ability to draw scientific conclusions.
- Working method knowledge e.g. instruments used within the
- Assist in the preparation/review of training modules in area of
- Mentors and develops others in the group through continuous and
- Write and review Analytical Procedures, Polices, SOPs and
Guides where appropriate.
- In-depth knowledge of study process from award to finalisation,
archiving and amendments to final reports.
- Employ effective general management, communication and
interpersonal skills to work within the project teams, with the
Client and other project stake-holders e.g. supporting functions at
- Participate in client and regulatory audits when required.
- Perform revenue recognition where required.
- Responsible for on-time delivery of data, project documents,
and quality documents.
- Ability to make decisions on assay results, suggest
assay/technique advancements/improvements to the client, and follow
through with the client as necessary Travel RequirementsThe role
will be primarily office based. It is anticipated that Client
visits / meetings will constitute approximately 10 to 20% of the
time in this role. Client visits and conferences including possible
weekend travel. Language Skills RequiredExcellent verbal and
communication skills with all principal contacts on a regular
basis. Required to communicate with Clients on a regular basis.
ExperienceThe post holder should typically have:
- Computing skills, including word processing and use of
spreadsheets (e.g. Microsoft Office packages and Microsoft
- An in-depth understanding of health and safety policies,
Company policies and procedures, and a good understanding of
- The post holder should be able to communicate effectively at
all levels with other Covance employees, as well as external
clients, suppliers, etc.
- The ability to get things done by influencing others (both
internal and external).
- Knowledge of capabilities and expertise of the Covance
organization and companies that may provide support services.
- An up to date knowledge of regulatory guidelines.
- Commercial awareness, interpersonal and negotiating
- Learn and maintain knowledge of process excellence processes,
tools and activities.
- Experience will have been gained in similar types of study
management (either internal or external).
- Experience of Client Management.
- Technical expertise in an appropriate scientific discipline.
Education/Qualifications/Certifications and LicensesThe post holder
should ideally have a relevant degree and/or 5-6 years industry
experience. Labcorp is proud to be an Equal Opportunity Employer:
As an EOE/AA employer, the organization will not discriminate in
its employment practices due to an applicant's race, age, color,
religion, sex, national origin, sexual orientation, gender
identity, disability or veteran status. For more information about
how we collect and store your personal data, please see our -
Keywords: Labcorp, Indianapolis , QC Scientist II-Cell Based Assays, Other , Greenfield, Indiana
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