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Lupin Pharmaceuticals · 1 week ago

QA Lead - Engineering Facilities Support

Coral Springs, FL

Full-time

Onsite

Senior Level

6+ years exp

Lupin Pharmaceuticals is a fast-growing and innovative company focused on generic and branded drug products. The QA Lead will oversee engineering documentation and ensure compliance with quality assurance standards while collaborating with cross-functional teams.

BiotechnologyPharmaceuticalRobotics

H1B Sponsor Likely

Responsibilities

Review of engineering documentation, protocols, records, and other related materials—both pre- and post-execution—pertaining to Engineering, EHS, and Facilities. This review is conducted in alignment with Good Documentation Practices (GDP), area specifications, defined parameters, and applicable regulatory requirements

Review equipment qualification/calibration/validation documents and computer system validation packages

Ensure adequate controls are implemented to achieve and maintain facility qualified state for their intended use

Review all pest control documentation and pertinent documentation from contractors

Communicate effectively with cross functional departments to ensure on time delivery of facilities and engineering documentation

Compile and review all applicable engineering and facilities documentation that is pertinent for batch review and release to ensure all QA batch disposition deadlines are met

Ensure adequate control of EM for temperature, humidity, pressure differentials. Perform review of investigations related to non-conformities related to EM

Review of tests results generated in support of environmental monitoring (EM) (viable and non-viable). Initiate QE for EM results not meeting acceptance criteria. Perform trend analysis and generate trend reports

Review of Quality events, incidents and deviations related to the facility, equipment and engineering and their impact on manufacturing processes/operations and laboratory operations

Follow all SOPs and Safety Guidelines to ensure compliance with a cGMP environment and Safety Practices

Serve as Subject Matter Expert (SME) during regulatory and internal audits as it pertains to quality systems and programs

Check all engineering and facilities notebooks and associated documents for correctness of raw data

Keep track of data and records review indicators from engineering and facilities for internal quality metrics and annual product review as appropriate

Identify and participate in internal quality improvement initiatives, evaluate internal processes, suggest improvements, create and revise relevant SOPs

Review all qualifications, validation and optimization reports

Ensure engineering and facilities staff follow all relevant SOPs and cGMP regulations

Ensure notebooks are reviewed in a timely manner, in accordance with SOPs

Perform additional tasks as assigned by QA supervisor

Qualification

CGMPQuality AssuranceValidation/QualificationLife Sciences degreeEnvironmental MonitoringSoft Skills

Required

Bachelor's degree in Life Sciences discipline

6+ years' experience within the QA group in pharmaceutical, biologic, medical device or regulated industry

Understanding of SOPs, validation/qualification concepts, HVAC, water systems, ALCOA and data integrity procedures, guidelines and requirements

Preferred

Previous experience with equipment/facilities management systems, cGMPs, EU GMP Annex 15, ASTM E2500, ISPE guidelines and ISO14644 standards for cleanrooms

Previous cGMP/regulatory experience

Company

Lupin Pharmaceuticals

Lupin Pharmaceuticals is a generic pharmaceutical company.

Founded in 2003

Baltimore, Maryland, USA

501-1000 employees

http://www.lupinpharmaceuticals.com

H1B Sponsorship

Lupin Pharmaceuticals 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 (3)

2024 (6)

2023 (2)

2022 (8)

2021 (6)

2020 (4)