Quality Assurance Specialist

Responsibilities

• Review batch records, Certificates of Analysis, and documentation for accuracy and completion.
• Author, revise, and manage approval of site policies and procedures.
• Review and approval of quality documentation, including deviations, change controls and CAPA, and complaints.
• Support supplier qualification program, including verifying supplier compliance with applicable quality requirements, focusing on critical materials, services, and supplier performance.
• Support ongoing production activities at Everett Laboratory.
• Support internal and external audits by preparing documentation, analyzing findings, and implementing corrective actions.
• Support project workstreams and continuous improvement project driven by Quality.
• Support implementation of Quality Management Systems.
• Support development processes for validation/qualification of equipment, facility, and/or manufacturing processes.
• Ensure data integrity compliance across quality systems, including adherence to ALCOA+ principles and 21 CFR Part 11 requirements.
• Balance quality requirements with safety, such as radiation safety, in all quality activities.
• Provide Quality support for ongoing production activities at Everett Laboratory.
• Perform other general duties associated with the position as required by supervision.

Qualifications and Skills

• Bachelor's degree in life sciences discipline, engineering, or a related field (or equivalent qualification through experience).
• 6+ years' industry experience in a regulated production environment (e.g., ISO 9001, cGMP pharmaceutical or radiopharmaceutical industries), including 3+ years of prior experience in a Quality Assurance role.
• Certification in a pharmaceutical Quality-related discipline, Lean Six Sigma or project management training/certification is a plus.
• Demonstrated experience working within Quality Systems.
• Strong working knowledge of quality principles, with proven success in managing complex projects and a wide range of responsibilities.
• Experience working within a quality program compliant to FDA/cGMP requirements Title 21 CFR 210/211 and ICH Guidance.
• Experience in a production radiopharmaceutical facility is preferred.
• Strong attention to detail, with the ability to interpret federal regulations, guidance and standards. Ability to incorporate relevant requirements into TPI documentation and provide guidance to personnel regarding compliance.
• Must demonstrate flexibility in adjusting to changing priorities and schedules in a dynamic environment.
• Occasional evening or weekend work might be required to support production operations or project deliverables.
• Strong interpersonal skills with demonstrated ability to lead cross-functional teams and drive accountability.
• Excellent written and verbal communication skills, including technical writing proficiency and executive-level reporting abilities.
• The successful candidate will possess a high degree of trust and integrity, communicate openly, and display respect while fostering teamwork.

Job Functions

• Motor Abilities: Sitting for extended periods, bending/stooping, grasping/gripping, fine motor control (hands)
• Physical exertion and/or requirements: Minimal, with ability to safely lift up to 25 pounds
• Repetitive work: Prolonged
• Special Senses: Visual and audio focused work
• Work Conditions: Stairs, typing/keyboard, standard and/or sitting working environment of >8 hours/day
• Travel required 5-15%

Benefits

• Competitive Compensation
• Comprehensive Medical and Wellness Benefits
• Medical Vision
• Dental
• Life and Disability
• Gender Affirmation Benefits
• Parental Leave
• 401k Plan
• Generous Paid Time Off (PTO)
• Generous Holiday Schedule
• Relocation Assistance
• Professional and Educational Support Opportunities