Quality Assurance Analyst II
Company: YPrime
Location: Raleigh
Posted on: February 24, 2021
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Job Description:
Is your career in its prime?? It could be! YPrime's Quality and
Compliance team is looking for a?Quality Assurance Analyst II to
help manage the quality management systems and investigations and
ensure that all documentation meets all regulatory requirements and
follows YPrime Standard Operating Procedures. You'll be based in
our?Raleigh, NC office.At YPrime, we help our clients in the pharma
and biotech industries to collect data from patients using mobile
devices, assign patients to study treatment groups and dispense
clinical trial drugs and supplies using web apps.? We're supporting
life-altering research, one project at a time.Does our mission
sound like something you can get behind?? If so, here's what we
need from you:* Bachelor's degree or equivalent * Experience in a
software environment* Microsoft Office experience with proficient
knowledge in Excel* Demonstrated analytical skill * Demonstrated
organizational skill * Excellent oral and written communication
skills * Extreme sense of detail orientation * Excellent time
management skills * Demonstrated ability to take initiative;
self-directed * A commitment to quality * Commitment to
follow-through * A positive attitude * A team-oriented spirit Have
these things too? Even better! * Experience with trending and
analysis on data from CAPAs and deviations* Well versed in 21 CFR
Part 11* Experience writing policies and/or procedures * Exposure
to and basic database knowledge (I.e. SQL Server, MySQL, MS
Access), or aptitude to learn quickly Here Are Some More Details
About The Job* You'll review and approve validation/verification
documentation and facilitate project/product releases for all
applicable environments* You'll serve as localized escalation point
for low and high severity issues arising from assigned locations.
You'll provide guidance and direction to key operational and
delivery stakeholders in matters of compliance and best practice.
You'll be responsible to escalate critical severity issues to QA
management* You'll assist in the development, implementation, and
maintenance of YPrime's Quality System, including facilitating
process improvement activities to the product and project teams
supporting continuous improvement, leading efforts in certain
areas* You'll perform and participate in internal audit to ensure
that Quality Standards are being adhered to* You'll act as a mentor
to Quality Assurance Analyst I* You'll conduct ongoing training and
support for new and existing staff on the Quality Manual and other
key areas including Corporate SOPs, GCP, 21 CFR Part 11,
validation, and process improvement/problem solving* You'll assist
in the maintenance of the corrective/preventive action (CAPA)
program, inclusive of tracking status of open actions, receiving
and reviewing responses, working with departments for timely
completion and periodic reports and metrics* You'll participate in
the evaluation of the quality events, incidents and possible
complaints or compliments and the appropriate follow-up* You'll
assist, manage, and/or maintain status tracking of internal audits
and responses, sponsor audits, and vendor audits* You'll support
the company during external inspections, as required* You'll
support/perform vendor assessment/qualification audits, as
required* You'll liaise with clients and suppliers where necessary
(where impacted/affected by quality concerns)* You'll perform other
duties as assignedWhat are the YPrime Perks? * Uncapped paid time
off * Comprehensive benefits package largely subsidized by YPrime *
401(k) with company match * Flexible working arrangements with an
emphasis on work/life balance * Friendly, smart, passionate and
hard-working coworkers * Opportunities for professional growth and
advancement
Keywords: YPrime, Raleigh , Quality Assurance Analyst II, Professions , Raleigh, North Carolina
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