Quality Specialist III QMS

HUMACYTE GLOBAL INC•Durham, NC

4h•Onsite

About The Position

The Quality Specialist III provides Quality oversight and support for Humacyte Quality Management Systems and processes, including documents, training and training metrics, change control, deviations, CAPAs. They will be the single point of contact for various GMP departments on site for day to day and project support and help ensure that GMP areas are compliant and under control. This person will also support internal and external inspections.

Requirements

Minimum 8 years of relevant pharmaceutical, biotechnical or medical device industry experience (including Document Administration, Quality Assurance, Quality Systems, regulated system administration, training development and delivery)
Background in one or more specialties in biotechnology: pharmaceutical and/or biological development, biomedical engineering, regenerative medicine or chemical engineering
Experience in writing and owning Deviations, CAPA’s and Change Controls
Develop and deliver comprehensive training materials, including Standard Operating Procedures, e-learning modules and “Train the Trainer” sessions.
Minimum 8 years of experience in GMP Quality Management Systems; MasterControl is a huge plus
Strong competency with Excel and Word
Strong background in both written and oral communication with emphasis on effective technical writing
May be required to work evenings, off-hours, holidays, or extended periods of time.
Demonstrated background in administration and support of GMP Quality management systems, and related applications
Experience in evaluating technical quality problems and providing recommendations for corrective actions
Strong understanding of cGMP, GDPs, data integrity requirements, ISO and ICH guidance’s in the biotech manufacturing environment. Understanding of biologics manufacturing operations preferred
Possess a positive roll-up-the-sleeves attitude and optimistic outlook.
Strong ability to work in a fast-paced team environment with fluctuating priorities and demonstrated ability to collaborate within cross functional teams.
Excellent organizational and time management skills with a keen ability to set own priorities in a timely manner.
High degree of flexibility and adaptability.
Self-motivated and critical thinker with outstanding interpersonal and business communication skills.
Represents the organization in a positive and highly professional manner.
Bachelor’s degree, required. Bachelor’s degree in Biology, Chemistry, Chemical Engineering or Biomedical Engineering, preferred
8 years of pharmaceutical work experience, preferably in Biologics manufacturing.

Nice To Haves

Understanding of clean room operations and aseptic processing, preferred

Responsibilities

Provide mentorship and support of more junior team members in establishing, maintaining, and monitoring the health of, quality systems.
Become an SME for the Quality Management System (QMS) and existing eQMS (MasterControl).
Provide document administration, training coordination, and document issuance support to the site.
Support metrics development, maintenance, and oversight.
Support the Quality Records Room and off-site record retention process.
Develop and maintain site Quality procedures as necessary.
Collaborate cross-functionally to provide general Quality oversight and support to various departments on site which includes support of routine work, representing Quality Assurance on project teams and in meetings, and reviewing and approving documents.
Ensure cGMP documents adhere to Humacyte policies, SOPs, and cGMP requirements.
Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Humacyte quality practices and make informed recommendations for resolution.
Represent Humacyte Quality by interacting with FDA, partner and supplier auditors/inspectors as needed.
Other duties, as assigned.

Benefits

Competitive base compensation and bonus
Stock Options
401k Plan with 4% Match and no Vesting Schedule
Medical, Vision and Dental Plans
Company Paid Long Term/Short Term Disability
Company Paid Life Insurance
Assortment of other voluntary benefits, including pet insurance; hospital indemnity; accident & critical illness plans; voluntary life insurance; legal protection plans and more
23 Days Paid Time Off (PTO) to start
10 Company Designated Holidays + 2 Floating Holidays
Paid Parental Leave Policies