Senior Quality Assurance Operations Specialist (Remote)

Location
Working from Home
Posted
Jun 09, 2022
Ref
4509882004
Required Education
Bachelors Degree
Position Type
Full time

SENIOR QUALITY ASSURANCE OPERATIONS SPECIALIST (Remote)

Position Summary:

This role is responsible for Quality Assurance Operations activities, including review of master and executed batch records, analytical data, method validation protocol and reports, stability protocol and reports, and batch disposition (API, drug substance, cell bank, Sterile bulk drug product, packaged/labeled drug product) for phase 1-3 clinical trials, process validation, and product launch.

Global Blood Therapeutics, Inc (GBT) places a high value on cooperative team dynamics and a positive, “can-do” work ethic.  The ideal candidate thrives in a fast-paced environment where a strong sense of urgency is the norm and exceptional communication, and interpersonal skills are needed.

Essential Duties and Responsibilities:

  • Review analytical data and Certificates of Analysis related to release testing and stability testing of small molecules and biologics
  • Review and approve test method transfer/qualification/validation protocols and reports, and stability protocols and reports, including auditing of analytical data associated with the executed protocols
  • Document review and batch disposition of product to be used in Phase 1, 2, and 3 Clinical Studies
  • Review and approve master batch records for compliance with regulatory and program requirements.  Ensure that the manufacturing process, equipment, and in-process test specifications meet phase appropriate GMP requirements
  • Participate and/or lead quality investigations, root cause analysis, and reviews or evaluations of events such as deviations, CAPA, changes, etc.
  • Review/approve (or assist in) documents such as SOPs, change controls, specifications, and test methods
  • Provide quality oversight of contract manufacturing and testing sites including quality records (deviations, CAPA, changes, etc.) and site performance
  • Support the organization in maintaining a work environment focused on quality and one that fosters learning, respect, open communication, collaboration, integration, and teamwork
  • As project team member, represent QA on product development teams including pre-clinical, phase 1, 2, and 3 development studies, commercial activities, and manufacturing improvement teams
  • Participate and/or lead quality improvement initiatives support quality improvement
  • Interpret Regulatory Authority regulations, guidelines and policies 
  • Communicate and ensure compliance with Quality objectives, policies and procedures

 Qualifications:

  • Minimum BS in a scientific related field
  • Minimum 5 years of experience in a GMP-regulated industry.  Experience in pharmaceutical industry is preferred
  • Must be detail oriented.  Attention to detail when reviewing documents and editing/proof-reading documents are required
  • Experience with analytical method transfer/qualification/validation
  • In-depth knowledge of ICH guidelines related to biologic product
  • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others and lead by example
  • Must be able to maintain a “big picture” perspective without losing sight of the details necessary to meet deliverables and deadlines
  • Strong and clear understanding of cGMPs and pharmaceutical industry best quality practices
  • Working knowledge of United States and European regulatory requirements, guidelines, and recommendations (additional jurisdictions a plus)
  • Excellent interpersonal skills with the ability to influence individual and teams across the organization
  • Able to work collaboratively in a matrix structure while ensuring that timelines and deliverables are met
  • Excellent verbal, written, interpersonal, organizational, and communication skills are necessary
  • Knowledge and experience with clinical phase-specific requirements is desirable
  • Ability to make decisions based on phase specific GMP requirements, and appropriate risk assessment is desirable
  • Experience in master and executed batch record review/release is a plus
  • Experience with interacting with CMOs is desirable
  • Experience in sterile manufacture preferred
  • Excellent problem-solving skills and experience with root cause investigations and CAPA determination
  • Self-directed and proactive individual with ability to thrive in a fast-paced, entrepreneurial, dynamic environment with high performing colleagues
  • Comfortable executing on multiple projects independently

 Fit with GBT culture:

  • Ability to build strong relationships with co-workers of various backgrounds and expertise
  • Ability to function at a high level in a team setting whether leading the group or acting as an individual contributor
  • Values-based leadership consistent with GBT's Core Values
  • Excitement about the vision and mission of GBT
  • Flexibility
  • Integrity

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

The Company complies with all laws respecting equal employment opportunity and does not discriminate against applicants with regard to any protected characteristic as defined by federal, state, and local law.  This position may require you to work onsite or interact in person with customers of the Company and/or work onsite from time to time at the Company’s facilities.  The Company requires all employees working in its facilities (including attending in-person meetings and events) to be fully vaccinated from COVID-19 (except as required by applicable law).  Therefore, this position requires you to be fully vaccinated from COVID-19, subject to reasonable accommodations for a disability/medical condition or sincerely-held religious belief, and/or as otherwise required by applicable law.  The Company considers you fully vaccinated once 14 days have passed since you received either the second dose in a two-dose COVID-19 vaccine series or a single-dose COVID-19 vaccine. This position requires you to maintain a fully-vaccinated status against COVID-19, subject to reasonable accommodations required by applicable law. The vaccine must have been FDA approved, have emergency use authorization from the FDA, or, for persons fully vaccinated outside of the U.S., be listed for emergency use by the World Health Organization.