Lead QA Batch Record Reviewer

18 hours ago


Piedmont, United States PL Developments Full time

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.A QA Batch Record Reviewer is responsible for ensuring the accuracy, completeness, and compliance of manufacturing batch records. The primary duties include reviewingdocumentation related to the production process, verifying adherence to standard operating procedures (SOPs) and regulatory requirements, and identifying any discrepancies or deviations. QA Batch Record Reviewers collaborate with production teams to address issues, provide feedback on documentation improvements, and ensure that products meet quality standards. Strong attention to detail, knowledge of relevant regulations, and effective communication skills are essential for success in this role.Work schedule: Monday - Thursday 5:30a to 4pJOB QUALIFICATIONS:Education: High School diploma or GED required; Associate degree preferredExperience: Minimum three (3) years of experience in GMP manufacturing environment; pharmaceutical experience preferredLanguage: Ability to read and interpret documents in the English languageMathematical Skills: Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals.Ability to use PC, calculator, and basic software (Microsoft Office); GMP software experience preferredAbility to read and follow cGMP, SOP and Safety guidelinesMust be able to work in a fast-paced environmentMust be detail-orientedMust have excellent communication skills across all levelsPOSITION RESPONSIBILITIES:Review and resolve open work orders in collaboration with QA Management and other departments, as necessaryTrain new QA Batch Record Reviewer employees on the responsibilities and processes to perform required tasksCalculate batch-related metrics and communicate at a determined frequencyProvide updates to QA Management regarding challenges preventing batch release as related to Reviewer responsibilitiesFacilitate resolution of batch-related issues through communication and collaboration with other departments and PLD sites as necessaryEnsure internal trackers for documentation and projects are maintained as instructed by Document Control Supervisor and perform periodic review for suspicious itemsEnsure filing system is maintained by Document Control PersonnelOversee annual batch record archival is completed by Document Control PersonnelReview production and laboratory-related batch paperwork to ensure complianceChange product status in the material management system and release finished goodsPlace and remove product on QA hold when requiredConfirm completion of batch-related investigationsRetrieve, file, scan, and archive batch-related documentsAssist with batch-related investigations as neededOther reasonable business-related duties as necessaryPHYSICAL REQUIREMENTS:Periodically stand and walkAbility to lift 10 pounds and occasionally push / pull / lift 25 poundsAdequate vision to accurately read numbers and batch paperworkBENEFIT OVERVIEW:PLD is a proud equal opportunity employer offering many corporate benefits, including:•Medical and Dental Benefits•401K•Group Life Insurance•Flex Spending Accounts•Paid Time Off and Paid Holidays•Tuition Assistance•Corporate Discount Program•Opportunities to Flourish Within the Company


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