HUD (Hospital Unit Dose) Specialist

Job Overview HUD (Hospital Unit Dose) QA Specialist responsibility includes the management of quality system projects related to cGMP compliance, documentation, specification review, non-conformance investigation and technical support related to Quality Assurance as well as environmental compliance monitoring relating to cGMP. The successful candidate will possess the ability to effectively communicate and develop professional relationships with internal and external parties. They are responsible for overall in-process and finished product inspection system, maintaining cGMP compliance in the facility.

ESSENTIAL FUNCTIONS

Responsible for supervising Incoming & Receiving as it pertains to HUD (Hospital Unit Dose) QHUD (Hospital Unit Dose). Responsible for up to first shift operations for all related HUD (Hospital Unit Dose) QA functions. Responsible for creating new packaging batch records. Responsible for assisting with annual product review for various HUD (Hospital Unit Dose) pharmaceutical products and report these to customers, as required. Responsible for preparing, reviewing and approving packaging orders as per customer specifications. Responsible for batch records review and perform reconciliation. Responsible for line clearance approval and documentation and to perform inspections when required. Responsible for maintaining master specifications for all products and making changes within the change control system, as required. Responsible for assisting Quality Assurance Director/Manager and Regulatory Compliance in responding to customer complaints. Creating a digital print mat as per customer specification. Maintain all digital print mats in HAPA printer. Responsible for making sure enough staff is available to support all HUD (Hospital Unit Dose) packaging lines for QA responsibility. Assign lot numbers and expiration dates if customer specifies. Responsible for making sure proper inspections are performed for each job and sampling is done according to customer specification, while meeting all cGMP requirements. Responsible for providing cGMP training to all Nutra-Med employees including QA Inspectors. Responsible for maintaining cGMP compliance in the facility. Assist QA Director/Manager and Regulatory Compliance during customer, FDA, DEA, or other regulatory agency audits. All other jobs assigned by HUD (Hospital Unit Dose) supervisor. Assign part numbers for inserts, labels, and/or cartons if customer requests.

Qualifications :

This position requires BS degree in scientific area or other related area with 2-5 years' experience in Quality Assurance or equivalent experience, preferred. The candidate should demonstrate strong interpersonal and communication skills, and the ability to self-start, plan, organize, document, and follow through on multi-task responsibilities.

Pay:

$23.00 - $25.00 per hour

Benefits:

401(k) Dental insurance Flexible spending account Health insurance Health savings account Paid time off Vision insurance Application Question(s): Will you now or in the future require sponsorship for employment visa status (e.g., H-1B visa)? Ability to

Commute:

Whippany, NJ (Required)

Work Location:

In person