Sr. QA Specialist (Fri-Sun 6am-6:30pm)

JOB SUMMARY

In support of biologics/gene therapy manufacturing operations, the Senior Quality Assurance Specialist champions collaborative day to day floor support, batch record review, and batch disposition. This role is accountable for all elements of the Quality Management System (QMS), including but not limited to deviations, Corrective and Preventive Actions (CAPAs), excursions, Out of Specifications (OOS), change controls, and upholding data integrity.

This role is aligned with the Manufacturing Friday-Sunday shift and the schedule is Friday-Sunday, 6am-6:30pm.

ESSENTIAL JOB FUNCTIONS 

• Oversee and provide regulatory compliance guidance during on-the-floor manufacturing activities.
• Support cGMP manufacturing operations through administration and enforcement of the Quality Management System including, but not limited to, deviations, change controls, and CAPAs.
• Review and approve documents from Manufacturing, such as SOPs, batch records, logbooks, training forms, etc.
• Perform Quality walkthroughs to maintain inspection readiness environment.
• Participate in batch disposition activities.
• QA support of drug product aseptic fill operations and vial visual inspections.
• Assist in deviation investigations, CAPA and Change Control implementations.
• Provide QA operation functional trainings, guidance, and mentorship to junior QA specialists.
• Support internal and external audits and inspections.
• Lead and support the Quality and production operation continuous improvement.

SPECIAL JOB REQUIREMENTS

• Adaptability required as work schedule may change based on business needs.
• Criminal background check required.
• Other duties as assigned

KNOWLEDGE, SKILLS AND EXPERIENCE

BS in science or engineering discipline	Desired
8+ years of relevant GMP experience in pharma/biotech company, working within a quality system and regulated GMP environment	Essential
Experience working in a cGMP manufacturing environment	Essential
Well versed in cGMP/ICH/FDA/EU regulations and guidelines	Essential
Proficient in using Microsoft applications (MS Outlook, MS Teams, MS Word, MS Excel, MS PowerPoint ect.)	Essential
Strong written and verbal communication skills to interact with cross function teams	Essential
Strong organizational skill	Essential
High level of attention to detail	Essential
Good problem-solving skills	Essential
Capable of working with minimal supervision	Essential
Ability to work well with diverse groups	Essential
Ability to multi-task in a fast-paced environment with challenging timelines	Essential

COMPENSATION RANGE:

The anticipated annual salary range for the Sr. QA Analyst is $100,000-$115,000. Salary determined based on relevant experience, skills and education.

PHYSICAL DEMANDS 

While performing the duties of this job, the employee is required to meet the following physical demands:

 

Work Environment:

• Frequently required to work in a BSL 2 environment with personal protective equipment/aseptic gowning.
• Regularly required to work around large machinery and typical utilities seen in pharmaceutical facilities.
• Occasionally exposed to moving mechanical parts; caustic chemicals; hazardous waste.
• Occasionally exposed to loud noise levels
• Spending time on the floor during activity execution (maintenance, construction, commissioning and qualification) is required.

Movement:

• Frequently required to stand; sit.
• Occasionally required to walk; climb or balance; and stoop/crouch.

Vision:

• Frequently utilize close vision and the ability to adjust focus

Communication

• Frequently required to communicate by talking, hearing, using telephone and e-mail