Quality Assurance Associate

The Quality Assurance Associate is responsible for routine inspection and testing of raw materials and components as well as of final product for Cresilon’s products in the Animal and Human Health industries. This position requires a strong attention to detail as the individual will be responsible for identifying deviations in product quality or safety and ensuring compliance with local, state, and federal regulations, including current Good Manufacturing Practices (cGMP).

RESPONSIBILITIES:

· Sample and perform visual inspection of final products and raw materials. Perform other testing under the direction of QA Operations Manager.

· Perform line clearance activities and in-process inspections.

· Monitor routine manufacturing operations for conformance to applicable procedures (see Gowning Qualification requirements below)

· Transfer materials between facilities (see lifting requirements below)

o Facility 1 of 2: 122 18th Street, Brooklyn, NY 11215

o Facility 2 of 2: 87 35th Street, Suite 603/604/6R, Brooklyn, NY 11232

· Operate testing equipment such as force testers, torque testers, and balances.

· Report all deviations in product, components, raw materials, and equipment per their relevant procedures

· Perform document control activities, including but not limited to printing logbooks and batch records.

· Transcribe data into digital systems for tracking Quality Metrics.

· Batch record review & support routine batch disposition

Requirements

Education:

· High School Diploma or Equivalent (2- or 4-year degree in Engineering, Science, or Technology/Biotechnology preferred)

Physical Requirements:

· Ability to lift, walk, stand, reach, pull and push

Preferred Qualifications:

· Required experience in GMP and FDA regulated environments (ISO 13485:2016preferred)

· Ability to be Gowning Qualified per Cresilon’s SOP.

· 1 year experience in regulated industry highly desirable

Benefits

• Paid Vacation, Sick, & Holidays
• Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage
• Company Paid Life and Short-Term Disability Coverage
• Work/Life Employee Assistance Program
• 401(k) & Roth Retirement Savings Plan with company match up to 5%
• Monthly MetroCard Reimbursement
• $20-25/HR

Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.