Trelleborg Sealing Solutions US-Tustin, CA, is part of Trelleborg’s Healthcare and Medical Segment, we provide innovative quality medical device assembly and packaging, as well as engineering services and combination products to our customers. We are a USA ISO 13485-2016 certified company, with all services performed in California. Currently, there is an opportunity in our Quality Assurance Department, for a Scientist specializing in Drug Device Development and supervising the Analytical Lab.
TSS is an Equal Opportunity Employer and offers an excellent benefits package that includes:
- Life Insurance
- Health Insurance
- Vision Insurance
- Dental Insurance
- 401(k) plan
Main responsibilities include providing quality leadership in the organization with a focus on cGMP pharmaceutical manufacturing of combination products. In the role, you would develop and improve processes that support the Quality System compliant to FDA, and ISO requirements. Other responsibilities include providing the Quality Control Unit responsibilities for combination products as well as project/product line support to internal and external customers.
Tasks and Responsibilities:
- Develops the Quality System (QS) to support combination products in compliance with drug cGMP manufacturing (FDA 21 CFR Parts 4, 210 & 211; EU 2003/94/EC, EudraLex Volume 4).
- Develops project plans related to systems development for and manufacturing of combination products. Schedules projects with definable objectives and due dates.
- Supports and approves development of facilities, utilities, cleanroom, equipment, production processes and controls, cleaning, inspection and testing and batch records for device and combination product.
- Conducts supply chain evaluations, audits, and approvals including, but not limited to, API manufacturers, processing facilities, analytical labs, etc. in accordance with ICH Q7, as appropriate.
- Supervises the analytical lab and chemist(s).
- Responsible for data integrity of all reported lab results.
- Has quality control unit responsibility and authority to approve or reject materials, components, in-process and sub-assemblies and final product.
- Supervises and performs combination product batch record reviews and authorizes product release to customers.
- Responsible for annual product reviews, as required.
- Responsible for managing API, materials and product retains.
- Supports customer complaint (CC) system per procedures. Performs investigations, determines disposition of returned goods, determines reinspection requirements, and determines corrective and preventive actions, issues complaint reports, completes customer corrective and preventative actions (CAPAs), and approves to close. Looks for trends to determine actions to decrease number of CCs.
- Maintains and approves Lab Investigation Reports (LIR), Out of Specification Investigations (OOS) and Non-Conforming Report (NCR) systems per procedures. Performs investigations, supports material review board (MRB) activities, determines recommendations for customer disposition, reinspection or retesting requirements, CAPAs, and approves to close. Looks for trends to decrease number of NCR’s or other issues and provides feedback to management.
- Supports corrective and preventive action system per procedures. Initiates CAPA’s, perform root cause analysis, implement CAPAs. Identifies trends.
Minimum Job Qualifications:
- Bachelor’s degree in Science or Engineering or any relevant technical degree, or equivalent experience.
- 9-14 years of pharmaceutical or combination product manufacturing industry experience.
- 2-4 years of supervisory or leadership experience
Knowledge, Skills and Abilities:
- Comprehensive understanding of drug cGMPs and ICH Q7.
- General understanding of drug GMP facilities, utilities and cleanroom requirements particularly for potent compound APIs.
- Comprehensive understanding of analytical laboratory testing.
- Comprehensive understanding of applicable Work Instructions, SOPs, USP and ISO standards.
- Demonstrated competence in using computer programs such as Word, Excel, PowerPoint, and programs associated with lab equipment.
- Effective project leader.
- Requires operation of lab equipment.
- Cleanroom environment including company provided cleanroom attire.
- Analytical laboratory environment with exposure to chemicals and active pharmaceutical ingredients (API).
- Restrictions on activities with respect to noise and air purity.
We welcome you to join our team during this exciting time!
Apply using this link: https://recruiting.ultipro.com/TRE1005TRLB/JobBoard/bf609905-b672-4f89-9d89-d81248503343/OpportunityDetail?opportunityId=bdb76b9e-a95d-4867-96f1-3b2ec7f99308