Join the Spark Team
We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.
We don’t follow footsteps. We create the path.
Primary Duties
The Sr. Quality Assurance Operations Specialist will:
- Review executed batch records and evaluate product and facility deviations; draw conclusions in terms of product disposition at Spark
- Review and evaluate QC testing records and any associated OOS investigations
- Review/Approve/Write/Revise Standard Operating Procedures and Technical Documents/Reports
- Provides general guidance/instructions to junior members of staff
- Work closely with QA, QC and Manufacturing Functional Management to identify strategies, tactics and objectives for product quality and GMP compliance
- Oversee GMP manufacturing operations
Responsibilities
90% of time:
- Conduct record review of executed production records for reagents, bulk drug substance, drug product and packaged lots.
- Review deviations, as appropriate, based upon Spark Manufacturing team and/or Contract Manufacturing Organizations (CMO) and/or Contract Technical Laboratories (CTL) notification; confirm evidence of on-time document closure for product disposition
Assure all Deviation/Investigations, Change Controls, CAPAs, and/or other required documentation related to the lots are completed and closed prior to material/lot release
Author and revise master production records, standard operating procedures and other documents used in the manufacture of clinical and/or commercial products
- Review, write, revise, approve SOP’s, technical documents and reports
Review vendor certificates for completeness / compliance against approved specifications
- Assist in audits of CMOs and/or CTLs.
Evaluate analytical results against approved specifications to determine compliance, release materials for use and/or provide an appropriate disposition for product
Prepare certificates of compliance (CoC) and/or certificates of analysis (CoA) for products for clinical and/or commercial materials
Evaluate lot test results against trending data to identify any irregular trends
Support preparation of regulatory submissions
10% of time:
- Other assigned responsibilities as established by QA Operations Lead.
Education and Experience Requirements
- BA/BS in scientific discipline required with a minimum of 5 years equivalent industry experience or MS with a minimum 3 years equivalent industry experience.
- Pharmaceutical manufacturing environment with exposure to Quality and Manufacturing field is recommended.
- Broad knowledge of relevant governmental regulations, cGMP and guidelines (US, EU and other territories where Spark products are distributed), and ability to organize cGMP procedures based on regulatory / compliance regulations
Key Skills, Abilities, and Competencies
- Broad knowledge of Quality Systems such as Change Control, Investigations and CAPA
- Ability to communicate effectively with wide range of personnel
- Solid technical writing skills related to investigation reports
- Ability to organize cGMP system procedures based on regulatory / compliance regulations
- Must have strong attention to detail
- Strong analysis and problem-solving skills, including, but not limited to, the ability to review and analyze Manufacturing, Quality Control and validation data
- Ability to lead (as necessary) and participate on cross-functional teams in root cause analysis and solution identification
- Proficiency with computer programs
- The position may require occasional shift work, including weekends, off hours and holidays as needed. May have occasional travel (less than 10%).