Quality Assurance Coordinator II

Key Responsibilities On-time batch record release with 100% accuracy; independently reviews and approves batch record documentation. Investigates and documents non-conformance issues; determines root cause and implements corrective and preventative actions. Detailed auditing. Identifies compliance gaps and develops, writes, revises, and reviews procedures. Preferred Skills Strong interpersonal, written, and oral communication skills. Strong statistical and mathematical calculation skills. Strong attention to detail. Ability to report trends. Qualifications Minimum 2 years of college education or equivalent experience with coursework in biology, chemistry, mathematics, or related fields. One year of experience in an FDA-regulated manufacturing environment. Detail-oriented with strong written and verbal communication skills. Experience in batch record release documentation review, QA, or equivalent. Strong investigation skills. Ability to advocate for a quality environment. Work Environment Manufacturing floor, warehouse, and office environment. Equal Opportunity Employer Pharmavite is an equal opportunity employer. We prohibit employment discrimination and harassment based on race, color, religion, age, sex, sexual orientation, gender, national origin, and any other basis protected by state and federal law. Pharmavite recruits, hires, employs, trains, promotes, and compensates individuals solely based on job‑related qualifications and abilities. Pharmavite also provides reasonable accommodation to qualified individuals with disabilities or a sincerely held religious belief, in accordance with applicable laws. #J-18808-Ljbffr Otsuka Pharmaceutical Co., Ltd