Lead QA Inspector - 3rd Shift jobs in United States
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PL Developments · 1 month ago

Lead QA Inspector - 3rd Shift

PL Developments LLC is a leading manufacturer, packager, and distributor of over-the-counter pharmaceutical products and consumer healthcare goods. The QA Lead plays a crucial role in ensuring quality and compliance in manufacturing and packaging processes by leading a team of QA Inspectors and maintaining regulatory standards.

BiotechnologyManufacturingPackaging ServicesPharmaceuticalProduct Management
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H1B Sponsor Likelynote

Responsibilities

Assist the QA Supervisor/Manager in leading the team of QA inspectors on the production floor
Assume leadership responsibilities in the absence of the QA supervisor and manager, overseeing daily operations and decision-making
Perform hourly quality checks of Work-In-Progress (WIP) and finished goods packaging according to company pre-defined attributes
Maintain outgoing production quality levels and assure compliance of cGMP’s
Verify lot number and expiration dates of finished packages against the Certificate of Analysis and pick slip
Verify that the production line clearance procedures have been correctly executed and approve the release of the line for operational use
Sign-off that the production line was properly prepared by annotation of the Equipment Use and Cleaning Log
Must have a clear understanding and be able to verify all documentation recorded and documented by compounding personnel
Understanding of adjustments to temperature, time, and speed controls required by (CF) compounding formulas. To be able to review ingredients and specifications for blending cycles as specified on (CF) compounding formula
Experience with characteristics of batches and raw materials preferred
Make certain all pertinent information and required signatures are present on various Batch Record forms
Pull and record retention samples
Pull and record “beginning”, “middle” and “end” production line retention samples
Make certain all required documents are present in the Batch Record
Perform kit inspection of staged components waiting to be processed; only as required
Perform accurate checks of the weigh scales, in-line scales, and leak detection equipment as needed
Perform cap torque measurements as required
Verify packaging specifications for customer packaging requirements
Assist the QA team with additional tasks as needed

Qualification

FDA/cGMP guidelinesOracleAgileMicrosoft OfficeEnglish communicationData entrySpanish communicationLeadership

Required

High School Diploma or equivalent
1+ years' experience in related field
Excellent oral and written communication skills in English; fluency in Spanish is a plus
Computer literate in Microsoft Windows and Microsoft Office
Knowledge of FDA/cGMP guidelines
Strong verbal and written communication skills

Preferred

Working knowledge of Oracle and Agile
Experience with characteristics of batches and raw materials

Benefits

Medical and Dental Benefits
Vision
401K with employer match
Group Life Insurance
Flex Spending Accounts
Paid Time Off and Paid Holidays
Tuition Assistance
Corporate Discount Program
Opportunities to Flourish Within the Company

Company

PL Developments

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PL Developments manufactures, packages, and distributes over-the-counter pharmaceutical products and consumer healthcare goods.

H1B Sponsorship

PL Developments has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (5)
2023 (1)
2022 (2)
2021 (1)

Funding

Current Stage
Late Stage
Total Funding
$500M
2024-10-28Debt Financing· $500M

Leadership Team

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Mitch Singer
President & CEO
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Company data provided by crunchbase