What are the responsibilities and job description for the Lead QA Inspector - 1st shift position at PL Developments LLC?
PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.
JOB SUMMARY:
The QA Lead plays a crucial role in ensuring the quality and compliance of the manufacturing and packaging processes. This position involves leading a team of QA Inspectors, ensuring quality control measures are followed, and maintaining regulatory standards to uphold product quality and safety.
Work Schedule: Monday - Thursday 6:00p - 4:30p
JOB QUALIFICATIONS:
- High School Diploma or equivalent
- 1 years’ experience in related field
- Computer literate in Microsoft Windows and Microsoft Office
- Working knowledge of Oracle and Agile, preferred
- Knowledge of FDA/cGMP guidelines
- Fluent in English, Spanish a plus
- Strong verbal and written communication skills
POSITION 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 assures 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 accuracy 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.
PHYSICAL REQUIREMENTS:
- Some light lifting (up to 25 lbs.).
- Frequent periods of standing and walking.
- Proficiency in typing and data entry.
- Mobility to move around the production areas and interact with employees as needed, which includes the ability to climb stairs to access designated work areas.
- Visual acuity to read and analyze documents, correspondence, and computer screens.
BENEFITS:
PLD is a proud equal opportunity employer offering many corporate benefits, including:
- Medical and Dental Benefits
- Group Life Insurance
- Flex Spending Accounts
- Paid Time Off and Paid Holidays
- Tuition Assistance
- Corporate Discount Program
- Opportunities to Flourish Within the Company
