Production Documentation Reviewer - Los Angeles, United States - Kindeva Drug Delivery Careers

Description

Kindeva Drug Delivery

Kindeva is a leading global contract developer and manufacturer (CDMO) with delivery platform expertise in Autoinjector, Inhalation, Transdermal/Intradermal Patch Technologies.

We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture many more tomorrows.
3rd Shift Opening - 9 PM-5:30 AM M-F


Summary:

To check production manufacturing documents, such as manufacturing orders (M.O.) and shop orders (S.O.) for completeness, accuracy, and adherence to good documentation practices before M.O.

and S.O. are submitted to QA.

Must be able to perform the essential functions of the job, as listed in the Essential Function Analysis Form, with or without a reasonable accommodation.

The essential functions and physical demands of this job can be found on the Essential Function Analysis Form for this position.

Responsibilities:

Core Job Duties**:

• Review each M.O., batch record and other production documents for accuracy & completeness.
• Correct errors by seeking out responsible individuals.
• Ensure & verify inprocess product quality audits completed & documented as required by MO instructions.
• Ensure shop order documentation of components are properly entered (i.e. receiver lot numbers, locations, quantities, initials).
• Check accuracy of shop order calculations.
• Deliver reviewed M.O.s to the shift supervisor for approval signatures.
• Deliver M.O. to the production planning tech for posting.
• Responsible for notifying the supervisor of QIR for OOS.
• Assist QSAs to resolve documentation issues.
• Attend weekly FOT meetings or review FOT meeting minutes to understand MO due dates.
• Close out batch records for all processes in dept.
• Must be proficient in serialization process.

Secondary Job Responsibilities:

• Become familiar with all processes in the department.
• Gives and accepts constructive feedback.
• Knows & uses good safety practices and takes ownership for running of a safe operation.
• Performs general housekeeping and cleaning of the assigned work area.
• Takes the initiative to help when required or needed with the total production operation.
• Performs other duties as requested.

Qualifications:

• Good understanding of batch record documentation requirements.
• Good attention to details.
• Basic math skills.
• Become proficient in the use of a calculator.

LI-Onsite

California residents should review our Notice for California Employees and Applicants before applying.


Covid-19:

Safety for our employees and our communities is a key priority for Kindeva Drug Delivery. Kindeva encourages everyone who can get vaccinated to get vaccinated.

Our Covid-19 task force monitors the external environment and will continue to evaluate our policies and procedures.


Equal Opportunity Employer:

Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law.