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Batch Record Reviewer

Company: Alpha Consulting
Location: Salt Lake City
Posted on: January 26, 2023

Job Description:

*BATCH RECORD REVIEWER**SALT LAKE CITY, UT**Shift: Friday-Sunday 6:00 pm-6:30 am, 12-hour shift, 4 hrs can be added to make this a 40-hr. position.**Required Skills: ** High School Diploma or equivalent required.* Associates Degree or higher (or equivalent) achieved or in process preferred.* Minimum of one year experience in a regulated environment such as pharmaceutical, medical device, nutraceutical, or food processing industries.* Basic understanding of Good Manufacturing Practice (cGMP) and the application to a production environment.* Computer proficiency with comprehensive working knowledge of MS Office products, Learning Management Systems (LMS), ERP systems such as SAP or Oracle and manufacturing/quality systems such as LIMS, Trackwise and Qdocs.* Self-directed with ability to organize and prioritize work.* Ability to communicate effectively with excellent written and oral communication skills.* Ability to interact positively and collaborate with co-workers, management, and external partners.* Problem Solving:* Proactively works on problems where evaluation of contributing factors requires the analysis of situations or data and an in-depth knowledge and evaluation of various known and unknown factors.* Seeks out all resources when selecting methods and techniques for obtaining results.* Acts independently and may proactively recommend methods and procedures for problem resolution.* Physical Requirements:* Frequent sitting for extended periods of time at workstation or mobile equipment.* Frequently using fingers to perform activities such as picking, pinching, or typing.* Frequent repetitive motions. (Frequent motions of the wrists, hands and/or fingers)* Occasional:* Standing for extended periods of time at workstation or equipment.* Walking to move short distances quickly and frequently.* Stooping, kneeling and/or crouching.* Twisting/Reaching - turning at waist and extending hands and/or arms in any direction.* Grasping - applying pressure to an object with the fingers and palm.*Project Description: ** Responsible for monitoring production operations through the use of multiple mechanisms including routine line checks, line clearance activities, in-process inspection oversight, providing general guidance and instruction to correct identified deficiencies during documentation reviews and other oversight as needed to ensure compliance with company procedures and domestic and international regulatory requirements.* Responsible for ensuring all site and regulatory requirements are satisfied for raw materials, labeling materials, and packaging materials prior to release.* Responsible for artwork review and approval, retain management and label issuance as needed to support operations.* Responsible for collecting, assembling, and managing information and making appropriate decisions on approval or rejection for all components, drug product containers, in-process materials, packaging materials, labeling, and drug products manufactured.* Responsible for conducting Foreign Matter Investigations as needed for materials throughout the lifecycle of the receipt, sampling, testing, dispensing and other in-process stages of material use.* Responsible for receipt, log in and management of incoming retains and in-house retains. This includes management of annual inventory, annual product reviews and destruction of materials which have exceeded expiry.* Responsible for serving as a QA "first responder" for various issues that occur on the manufacturing/ packaging floor and/or during batch record documentation/review and providing directions for situations of low complexity; moderate to high complexity situations must be deferred to more senior QA personnel.* Responsible for labeling issuance, review and/or returns; document processing including data entry, data verification and/or processing/controls of documentation.* Responsible for participating in investigations and providing recommendations for corrective actions and prevention of recurrence.* Responsible for writing, revising, or reviewing Standard Operating Procedures (SOP's), forms and/or Work Instructions with changes of low complexity and responsible for ensuring accuracy and GMP compliance in documents that are being reviewed such as artwork, raw material files, AQL inspection forms, and labeling.* Responsible for performing additional related duties as assigned.This 6+ month position starts ASAP.ALPHA'S REQUIREMENT #23-00141MUST BE ELIGIBLE TO WORK IN THE U.S. AS AN HOURLY W2 EMPLOYEEJob Types: Full-time, ContractBenefits:* 401(k)* Dental insurance* Health insurance* Health savings account* Referral program* Vision insuranceSchedule:* 12 hour shift* Night shift* Weekend availabilityWork Location: One location

Keywords: Alpha Consulting, Salt Lake City , Batch Record Reviewer, Other , Salt Lake City, Utah

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