Quality Lab Administrator - Irvine, United States - Nutrawise Health & Beauty LLC

Description

:

The QC Coordinator will follow current Good Laboratory Practices (cGLP) and support QC laboratory systems to ensure the chemical and microbiological integrity of all raw materials and finished products as defined by their respective specifications.

Accountable for timely coordination of QC functions including releasing raw materials and finished product CofAs to meet production scheduling requirements and customer deadlines.

Maintain Labware functions including lot creation, specification creation and handling of OOS.

Nutrawise Health & Beauty, located in Irvine California, is a leading manufacturer of health and wellness supplements including the award winning line of youtheory products which are sold in over 50,000 retailers worldwide.

With over 100 years of combined service in the natural foods and supplement industry, Nutrawise executives are committed to its mission of being a purpose built company that continually supports a wide range of charitable organizations both locally and globally.

If you are looking for a company that values and develops it's employees while offering engaging work, Nutrawise may be the place for you.

Our people are what makes us a great company. We're growing fast and we want you along for the journey


Requirements:

• Coordinate and maintain all QC & laboratory systems, cGLP systems and support overall Quality Team.
• Back up to QC Technician/Sampler job duties as required.
• Coordinate lab functions to meet production scheduling requirements and customer due dates for releasing raw materials and finished product CofAs.
• Responsible for timely receipts of all Raw Materials and Labware lot creation for Samplers.
• Conduct RM documentation testing including Supplier CofA Verifications and Certified Documentation tests.
• Log samples and set up testing in Labware for investigation samples, resampling for OOS, FP reworks and any 'ad hoc' sample/testing requests.
• Create sample requests for QC support as required.
• Responsible for all RM releases in Labware and Deacom and all FP CofA releases in Labware.
• Print release or status labels for RM containers.
• Responsible to track raw material retest/expiry date program, initiate retesting as required and attend required meetings on HOLD/REJECT status updates.
• Complete QC deviations including warehouse damage deviations related to RM receipts as required.
• Responsible for handling and coordinating all Out of Specifications (OOS) in Labware and completing OOS reports, OOS deviations and providing Q10 status updates.
• Conduct Formal sample AQLs as required.
• Create and prepare Labware raw material specifications and finished product specifications. Complete all Change Requests for specification revisions.
• Lead projects for major specification updates including supplier follow ups for spec alignment, as required.
• Coordinate Environmental Monitoring Program including review of monthly reports.
• Perform production batch potency adjustments.
• Maintain system of tracking lab supply purchases and order lab supplies monthly as required.
• Fulfill retain and QC document requests as required.
• Assist with quality audits and technical tours of the facility.
• Prepare and revise QC SOPs as required.
• Prepare Technical Documents and Study Protocols and special projects as required.
• Other duties and assignments as required

Qualifications and Behavioral Requirements:

• Minimum Technical Diploma in Science related field from an accredited postsecondary institution
• Minimum 2 years laboratory practical experience in a pharmaceutical, nutritional, food or health products manufacturing laboratory environment
• Comprehensive knowledge of laboratory systems and cGLP
• Familiar with USP, AOAC, FCC and other standards or compendia used in the food and drug industry
• Experience in nutraceutical/pharmaceutical manufacturing environment an asset
• Excellent communication skills and report writing
• Excellent problem solving skills
• Proficient with computers
• Experience with manufacturing and inventory management software, LIMS software systems, and other Quality System database systems an asset
• Team oriented focus
• Selfstarter and critical thinker
• High work ethic standards a must
• Ability to work with mínimal supervision
• Able to work shift work for job coverage as required.
• Able to work overtime when workload volume is high and to complete special projects as required

Benefits

• Competitive salary, including discretionary performancebases bonuses.
• Health Benefits (medical, dental, vision)
• Life Insurance
• 401(k) Matching
• Flexible Spending Accounts
• Employee Assistance Program
• Vacation Time
• Employee Recognition Programs
• Learning & Development
• Work/Life Balance
• Fun Company Events