The QA Coordinator/Product Compliance reviews documentation for product release, helps with the initiation of non-conformance reports, critical change requests and regularly updates their respective status. This position may also assist with Customer Complaint Investigations which includes interacting with customers and health care professionals.

ESSENTIAL DUTIES AND RESPONSIBILITIES

include the following. Other duties may be assigned. Performs review of production batch record; Regularly informs upper management about product release status; Assists in all audit activities by keeping track of pertinent audit files; Documents the initiation of Non-Conformance Report (NCR) as well as regular follow ups on NCR status; Documents the initiation of Critical Change Requests (CCR) as well as regular follow-ups on CCR status; and Assist with customer complaint investigations

EDUCATION AND/OR EXPERIENCE

Bachelor of Science degree in a related scientific discipline from an accredited college or university. Two (:2) years Quality Assurance and/or quality control experience in pharmaceutical industry is desired. or equivalent combination of education and experience.

Knowledge of:

Current cGMPs, SOPs and FDA. and other regulatory compliance regulations and standards. Business. scientific and personal computer hardware and software applications. Business English usage. spelling grammar and punctuation. Principles of mathematical computations. Sunshine Act Amphastar reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Amphastar to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Amphastar intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Amphastar that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. EEO & Employment Eligibility Amphastar is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Amphastar also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Amphastar is an E-Verify employer. Amphastar is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Job Type:

Full-time Pay:

$25.40 - $26.40 per hour

Benefits:

401(k) 401(k) matching Dental insurance Health insurance Health savings account Life insurance Paid time off Referral program Retirement plan Vision insurance

Education:

Bachelor's (Preferred)

Work Location:

In person