Lead Quality Assurance Specialist (50246)

OCUSOFT•Rosenberg, TX

7d•$65,000 - $75,000•Onsite

About The Position

The Lead Quality Assurance Specialist is responsible for overseeing quality assurance activities within a cosmetic manufacturing environment to ensure compliance with FDA regulations, GMP standards, and internal quality systems. This role provides leadership to QA staff, supports manufacturing operations, and ensures that finished products, raw materials, and processes meet established quality, safety, and regulatory requirements.

Requirements

Bachelor’s degree in chemistry, Biology, Microbiology, Chemical Engineering, or a related scientific field preferred but not required
Minimum of 5 years of QA experience in cosmetic, personal care, pharmaceutical, or regulated manufacturing environments.
At least 1–2 years in a lead or supervisory QA role required.
Strong working knowledge of cosmetic GMPs, FDA regulations, and quality systems.
Experience with batch record review, deviations, CAPA, and audits.
Familiarity with microbiological controls, stability programs, and cosmetic safety requirements.
Excellent attention to detail, documentation, and organizational skills.
Strong leadership, communication, and problem-solving abilities.
Proficient in MS Office and electronic QMS systems.
Ability to work in a manufacturing environment, including standing for extended periods.
Must be able to wear required PPE.
Occasional overtime or off-shift support may be required.

Responsibilities

Lead and enforce compliance with FDA cosmetic regulations, GMP (21 CFR 210/211 as applicable), ISO standards, and company quality policies.
Maintain and improve Quality Management Systems (QMS), including SOPs, work instructions, and records.
Serve as a subject matter expert for cosmetic GMP requirements and regulatory expectations.
Support internal and external audits (customer, regulatory, and third-party) and ensure timely corrective actions.
Provide QA oversight during manufacturing, filling, labeling, and packaging operations.
Review and approve batch records, production documentation, and deviations.
Ensure proper line clearance, in-process controls, and adherence to approved specifications.
Address quality issues on the production floor and guide teams toward compliant resolutions.
Lead, mentor, and train QA Specialists and Inspectors.
Assign daily QA activities and ensure adequate coverage across shifts.
Review QA documentation completed by team members for accuracy and completeness.
Promote a culture of quality, compliance, and continuous improvement.
Lead or support investigations related to deviations, nonconformances, complaints, and OOS/OOT results.
Develop and track corrective and preventive actions (CAPAs).
Perform root cause analysis and recommend process improvements.
Review and approve raw materials, packaging components, and finished goods for release or rejection.
Ensure proper sampling, testing, and documentation in coordination with Quality Control.
Maintain control of nonconforming materials and quarantine processes.
Ensure employees are trained on GMPs, SOPs, and quality requirements.
Maintain training records and support onboarding of new QA and manufacturing personnel.
Assist in document control activities including revisions and approvals.