This position is responsible to manage, plan, organize, direct and evaluate all activities and staff to ensure that in-coming raw materials, in-process paste from LA, Labeling and packaging materials, components are tested and dispositioned in a timely manner and providing Â Quality oversight and supporting Â of Engineering Functions (Metrology, Critical Utilities, Pest Control) are in compliance with site and Global standards. This position will provide control and oversight over the REJECT CAGE/ TEST MATERIAL CAGE and QUARANTINE CAGE. Work closely with Critical Utilities, Warehouse and QC Labs to support manufacturing and product support teams to ensure disposition and investigations related to Testing of Raw Materials, Critical Systems and receiving of RM for the site. Â This position will support to drive improvements in safety, customer satisfaction, employee development, continuous improvement, and financial performance consistent with Plant objectives. This position will make critical decisions to disposition raw materials and supporting Engineering (Metrology / Critical Utilities)
Should provide Strong leadership, project and people management skills, and ability to make critical decisions. Willing to learn new aspects of the business.
Hire and retain great talent, develop, coach and provide challenging work for team members; support the career development of their employees. Manage people performance, compensation and development.
Assure a safe and non-discriminatory working environment for employees.
Develops and manages operating budget for lab with regards to external testing, calibrations and equipment upgrades etc. Â
Ensure compliance with testing procedures, specifications and company policies. Prepare the department for both internal and external authorities during audits.
Ensures that staff supports timely disposition of materials and the departmental matrix are maintained.
Provide cross training opportunities between QARI and Critical Utilities and provide support and Quality oversight of Engineering Functions (Metrology, Critical Utilities).
Provide quality representation in EAC meetings and support the PQR for both the products (IG and Albumin).
Ensure the departmental SOPs, JAâs, ICQAâs, site Specifications, test procedures are current.
Ensure the triages occurring in the CUB are responded andÂ completed in a compliant manner.
Reviews the results and determines whether to accept or reject the incoming material during inspection process.
Prepares weekly and monthly summary reports to be shared internally and externally with departmental KPIâs.
Ensure change control and TW deviations for the area of responsibilities are initiated and closed in a timely and compliant manner. Â
Coordinates customer complaint response SCARS are initiated as needed for defective material.
Conduct gap analysis of site procedures with global documents and rectifiy as needed.
Ability to Navigate Global Supplier Quality Trackwise (GSQ TW), Trackwise 8 (TW 8), JDE and Laboratory Information Management System (LIMS).
Supports internal and external inspection in aspected of BAS alarms, Pest Control, Metrology Deviations, QARI in-coming activities, REJECT and TEST material cages etc. Â
Ensures the QA laboratory area and sampling area is always maintained in a GMP state while following all EHS guidelines.
Write and execute validations forlaboratory instruments and methods.
Work on special projects / protocol testing that involves new methods and instrumentation Ensure Â all testing comletion, including special project / protocol testing in a timely and appropriate manner.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, and cGMP regulations.
Participate / lead teams which impact production, increase efficiency, solve problems, generate cost savings, improve quality and provide new product support.
Support warehouse and be able to provide guidance for Warehouse operations in regards to Â Incoming receipt quality issues and BAS alarm review.
Typically requires bachelor's degree in science, engineering or other related technical field. 4+ years of related experience in pharmaceutical or similar regulated industry.
Working knowledge of statistics and production processes.
Strong communication skills are needed to effectively supervise support personnel.
Must have good knowledge about External Supplier Quality
Must have good understanding and knowledge about Metrology and Critical Utilities from generation to distribution.
Ability to navigate through Track Wise and Veeva
Decision to accept or reject material.
Solving issues related to material availability.
Releases to support manufacturing operation in regards to RM and labeling.
Ability to perform departmental investigation (safety, SOP violation, Out of spec. etc)
Must be able to lift, push, pull and carry up to 20 lbs.
In general, the position requires a combination of sedentary work and walking around observing conditions in the facility (warehouse/ CUB/ Level 0 for manf. Building).
Must be able to work in controlled environments requiring special gowning (ISO 8 and 9) and very cold environment (-20 C). Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
USA - GA - Social Circle - Hwy 278
Internal Number: R0027229
About Biolife Plasma Services
Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare diseases. While you focus on our donors, we’ll support you. We offer a purpose you can believe in, a team you can count on, opportunities for career growth, and a comprehensive benefits program, all in a fast-paced, friendly environment.