TDD Production Document Reviewer
3 weeks ago
Posted Thursday, March 14, 2024 at 4:00 AM | Expires Friday, March 22, 2024 at 3:59 AM
ROLE SUMMARY
The TDD Production Document Reviewer is responsible for the review of Manufacturing Orders (MOs) & all other production documents. For example: Equipment Clean, Use, Maintenance (ECUM) Logbooks, & Clean Check Logbooks. Leveraging their experience as a TDD Production Operator they will ensure MOs & all other production documents are Right First Time (RFT) to submit to QSA. This hourly position starting rate is $25.44.
ROLE RESPONSIBILITIES
- Review all MOs and production documents for accuracy & completeness.
- Correct errors by seeking out responsible individuals.
- Ensure & verify in-process product quality audits are completed & documented as required per MO instructions.
- Deliver reviewed M.O.s to the Production Supervisor for approval signatures.
- Deliver completed M.O.s to QSA for final review.
- Responsible for notifying the Production Supervisor of potential QIR
- Assist QSAs to resolve documentation issues.
- Close out all M.O. and other production documents for all processes in dept.
- Proficiency in the use of D365
- Must be proficient in serialization process.
- Perform other duties as assigned.
BASIC QUALIFICATIONS
- High school education or equivalent. Applicants with college education or technical certification preferred.
- Experience working in a GMP, OSHA, FDA regulated industry preferred.
- Ability to communicate clearly and concisely, both orally and through written transmission.
- Must be able to work standard 1 st , 2 nd , or 3 rd shift
- Must be able to lift (40) pounds unassisted
**Must be able to stand and walk for long periods of time while working.
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.
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