Quality Assurance Operations Specialist

Location
San Francisco, CA, United States
Posted
Nov 02, 2018
Ref
360
Hotbed
Biotech Bay
Required Education
Bachelors Degree
Position Type
Full time
QUALITY ASSURANCE OPERATIONS SPECIALIST

Job Summary:

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

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 API, bulk drug product, and packaged/labeled drug product to be used in Phase 1, 2, and 3 Clinical Studies
  • Review and approve master batch records for compliance with regulatory requirements. Ensure that the manufacturing process, equipment, and in-process test specifications meet phase appropriate GMP requirements
  • Participate in quality investigations, assessments, 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
  • 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
  • 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 3 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 stability (Q1A-Q1F), Analytical Validation (Q2), and Specifications (Q6A-Q6B)
  • Strong analytical and communication skills as well as sound judgment, with the ability to work effectively with others
  • 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

Desirable Qualifications:
  • 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 batch record review/release is a plus
  • Experience in review of master batch records is a plus
  • Experience with interacting with CMOs is desirable
  • 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.

Global Blood Therapeutics is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.