Medix™
This role supports Quality Assurance activities across analytical, laboratory, and product development functions in a regulated pharmaceutical environment. The position ensures that documentation, data, and processes comply with cGMP and internal quality standards while supporting batch release, stability, and continuous improvement activities.
Required Qualifications
Strong knowledge of cGMP and regulatory requirements.
Strong organizational, documentation, and time‑management skills.
Proficiency in Microsoft Word and Excel.
Strong technical writing skills; ability to provide writing samples upon request.
Ability to work independently and collaboratively in a cross‑functional team environment.
Key Responsibilities
Provide QA support for analytical testing, product development, and formulation activities, including protocol review and approval.
Review and approve analytical reports; interpret data to ensure compliance with specifications and regulatory expectations.
Support review of CMC sections of regulatory submissions such as abbreviated new drug applications (ANDAs).
Manage document activation, control, and distribution for SOPs, specifications, protocols, and related controlled documents.
Review, interpret, trend, and approve stability study data.
Issue and maintain preventative maintenance and calibration documentation.
Support laboratory audits and inspections, including preparation and follow‑up activities.
Maintain, issue, and review batch records; perform final batch record review, release, and pedigree issuance.
Support and maintain data within specialized quality and laboratory systems, including calibration systems, document management systems, and temperature monitoring systems.
Author and support deviation, incident, and investigation documentation.
Provide technical and quality support to laboratory, manufacturing, and product development teams as needed.
Seniority Level Not Applicable
Employment Type Full-time
Job Function Quality Assurance
Industries Staffing and Recruiting and Pharmaceutical Manufacturing
Medical insurance
Vision insurance
401(k)
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Required Qualifications
Strong knowledge of cGMP and regulatory requirements.
Strong organizational, documentation, and time‑management skills.
Proficiency in Microsoft Word and Excel.
Strong technical writing skills; ability to provide writing samples upon request.
Ability to work independently and collaboratively in a cross‑functional team environment.
Key Responsibilities
Provide QA support for analytical testing, product development, and formulation activities, including protocol review and approval.
Review and approve analytical reports; interpret data to ensure compliance with specifications and regulatory expectations.
Support review of CMC sections of regulatory submissions such as abbreviated new drug applications (ANDAs).
Manage document activation, control, and distribution for SOPs, specifications, protocols, and related controlled documents.
Review, interpret, trend, and approve stability study data.
Issue and maintain preventative maintenance and calibration documentation.
Support laboratory audits and inspections, including preparation and follow‑up activities.
Maintain, issue, and review batch records; perform final batch record review, release, and pedigree issuance.
Support and maintain data within specialized quality and laboratory systems, including calibration systems, document management systems, and temperature monitoring systems.
Author and support deviation, incident, and investigation documentation.
Provide technical and quality support to laboratory, manufacturing, and product development teams as needed.
Seniority Level Not Applicable
Employment Type Full-time
Job Function Quality Assurance
Industries Staffing and Recruiting and Pharmaceutical Manufacturing
Medical insurance
Vision insurance
401(k)
#J-18808-Ljbffr