ARx Quality Technician

2 weeks ago

Glen Rock, United States ARx, LLC Full time

Job Summary:

Manages & performs quality systems functions.


Essential Functions:

Independently prioritizes workload based on input from other functions, customer needs and business requirements.

Ensures GMP compliance in Manufacturing, Quality and R&D.

Review of in process documentation in manufacturing and analytical areas for compliance to ARx good documentation practices and effective procedures.

Comprehensively, accurately and independently conducts final review of all batch records, line clearances, supporting data and testing requirements assuring compliance with documented procedures, federal regulations and customer requirements.

Issues controlled documentation to manufacturing, QC and R&D as required.

Assist as a backup for operations for any manufacturing signoffs or approvals as needed.

Assist in line clearance as required.

Assist in quality inspection and sign off of manufacturing equipment as needed per standard operating procedures.

Participates in internal audits as required.

Organizes and administers filing and archiving of all quality records and information including controlled substance tracking and audit records; does so consistent with LEAN 6S principles; assures records are retained consistent with Quality Agreements and appropriate regulatory requirements.

Generation of product labeling used during manufacturing.

Issue batch records, labels, forms for use in production. Verify product lot number prior to batch record issuance. Review batch records and supporting documentation for accuracy, completeness and compliance.

Facilitates product release and generation of certificates of compliance and analysis upon successful completion of batch record review and QC testing.


Additional Responsibilities:

.

Comply with all Corporate Safety policies.

Perform other duties and responsibilities as assigned.


Job Specifications:

Bachelors degree in technical or engineering discipline preferred but not required and/or a minimum of 2 years of quality experience in Quality Systems; working knowledge of cGMP and GLPs.Evidence of continuing education such as professional certification (ASQC) desired.

Ability to perform required duties independently, efficiently and effectively with minimal supervision.

Able to use initiative in carrying out assignments independently without specific instructions; exercises sound judgment and discretion regarding when to request guidance and/or assistance from others.

Ability to thoroughly review documents for accuracy and completeness.

Ability to read and interpret documents such as test methods and procedure manuals.

Ability to work with mathematical concepts such as averages, standard deviation and other basic statistical functions.

Ability to operate computers and other office equipment; software package (e.g. Oracle, MS-Outlook, MS-Excel, MS-Word, Minitab, PDFs, Sharepoint, scanning, etc.) competence for drafting documents as well as inputting, tabulating and retrieving data.

Work environment can involve moderate risks or discomforts requiring special safety precautions, may be required to use personal protective equipment.

Ability to maintain confidentiality of company and client information.

Ability to conduct duties and interact with others (colleagues & external parties) in a professional manner.

Ability to understand and conform to Company policies and procedures.

No relocations assistance, must be local

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