Senior Specialist, Quality Assurance
About Us:
Aliri is committed to solving industry challenges by bringing innovative bioanalysis and spatial solutions to biotech and pharma, as the complexity of the drug development landscape continues to rise.
Primary Purpose:
To serve as senior-level Quality Assurance Specialist within the Contract Research Organization (CRO). This position is suitable for individuals with a bachelor's degree, experience in a regulated environment, and significant experience in quality assurance, offering increased responsibilities and autonomy as an individual contributor.
Job Duties and Responsibilities:
•Audit Planning and Execution: Prepares and executes quality assurance audits: project specific audits, facility audits, vendor qualifications in accordance with internal procedures and appropriate regulatory guidance.
•Ensures that systems used in QA are properly maintained (e.g., QA audit records, training records).
•Evaluates responses to inspection reports and performs follow-up with respondents, QA management, or others, if needed, to ensure resolution.
•Reports quality issues to QA management, PAI, TSM, SD, and TFM (as appropriate).
•Performs other related duties as assigned.
•May participate in sponsor audits, which includes answering questions, note taking, and gathering documentation.
•Manages all aspects of personal, daily micro-scheduling, organization and prioritization related to a full workload.
•Audit/review laboratory SOPs and QAU specific SOPs for compliance.
•May participate in regulatory audits, answer applicable questions, act as a scribe and gather documents for the lead auditor as needed.
Experience:
Bachelor's Degree in Chemistry or Technical Writing related Scientific field with 6-8+ years experience is required -OR- Master's Degree or equivalent in Chemistry, Technical Writing or related Scientific field with 5+ years experience is required -OR- Ph.D. or equivalent in Chemistry, Technical Writing or related Scientific field with 2+ years experience is required
Knowledge, Skills, and Abilities:
•Intermediate understanding of quality assurance principles and regulatory requirements.
•Proficient in auditing processes and documentation review.
•Strong analytical and problem-solving skills.
•Ability to work independently and collaboratively.
•Effective communication and collaboration skills.
Preferred Qualifications:
Proficient in technical writing
Electronic QMS
Working Conditions:
This position is regularly performed in an in-person office environment, which means the physical surroundings are generally pleasant and comfortable with minimal exposure to injury or other hazards, with a moderate level of noise. Prolonged periods of sitting and looking at a computer screen with freedom of movement on a regular basis is expected. Minimal physical effort is required but could include: repetitive motion of wrists and fingers; talking and hearing; and handling of light materials and supplies. This position will require less than 10% of travel.
Benefits:
Medical and Dental Insurance through United Health Care
Qualified High Deductible Health Plan with an employer HSA contribution
Qualified High Deductible Health Plan with an employer HSA contribution
PPO Copay Plan, with choice of FSA
Dental PPO Plan
Vision insurance through VSP
Additional life insurance options
Employer Paid Basic Life & Accidental Death & Dismemberment (AD&D)
Accident and Critical Illness and hospital indemnity plan
Health savings and Flexible spending accounts
Bonus Plans and rewards and recognition programs
401K with matching
Fitness and Warehouse Club reimbursements