Top 4 Hplc Jobs in San Antonio, Tx

Director of Quality
APOCUS —San Antonio, TX
- $100,000 - $145,000 a year
- Full-time
- 5 years
- Laboratory experience
- Doctor of Philosophy
- Paid holidays
- Relocation assistance
Quick Apply
5d
Analytical Chemist
APOCUS —San Antonio, TX
- $57,000 - $70,000 a year
- Full-time
- Background check
- Master's degree
- Bachelor's degree
- Health insurance
- Dental insurance
Quick Apply
10d
Quality Control Scientist III
Velocity Bioworks Inc —San Antonio, TX
- Weekends as needed
- Customer service
- 3 years
- Bachelor's degree
Quick Apply
Quality Supervisor, Nights
Refresco —San Antonio, TX
- Weekends as needed
- Bachelor of Science
- Mid-level
- 3 years
- Health savings account
- AD&D insurance
Quick Apply

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Director of Quality

APOCUS
San Antonio, TX

Quick Apply

Job Details

Full-time
$100,000 - $145,000 a year
5 days ago

Benefits

Paid holidays
Relocation assistance
Health insurance
Dental insurance
Paid time off
Vision insurance

Qualifications

Biology
Document control experience within pharmaceutical industry
Preventive action implementation
Drug regulation
Compliance audits & assessments
Laboratory experience
Corrective and preventive actions (CAPA)
Quality control audit
Manufacturing facility experience
Production validation processes
Quality risk management
Pharmaceutical company experience
Compliance documentation
Regulatory/legal compliance standards in production
Sterile products production
Production batch record review
Managing product quality assurance teams
Master of Business Administration
FDA regulations
Customer complaint resolution
Pharmaceutical manufacturing facility experience
Laboratory compliance and regulatory documentation

Full Job Description

Director of Quality

Location: San Antonio, Texas
Relocation Assistance: Available
Visa Sponsorship: H-1B Transfer Sponsorship Available for Qualified Candidates
Reports To: Chief Executive Officer
Industry: Pharmaceutical Manufacturing / FDA Registered 503B Outsourcing Facility

Position Summary

We are seeking an experienced and highly motivated Director of Quality Assurance to lead and manage the Quality Assurance function at our FDA-registered 503B Outsourcing Facility. This individual will oversee all aspects of the Quality Management System (QMS), lead a team of Quality Assurance professionals, ensure compliance with current Good Manufacturing Practices (cGMP), and serve as a key leader during FDA inspections and regulatory audit including 483.

The ideal candidate will possess extensive experience in sterile pharmaceutical manufacturing, quality systems management, FDA inspections, CAPA, change control, deviation investigations, batch record review, and continuous quality improvement initiatives.

Key Responsibilities:

Quality Leadership

Lead, mentor, and develop a team of 3–5 Quality Assurance professionals.
Establish a culture of quality, compliance, accountability, and continuous improvement.
Serve as a member of the site's leadership team.

Quality Management System (QMS)

Develop, implement, and maintain robust Quality Systems in compliance with FDA cGMP requirements.
Own and manage:
SOP creation and revisions
Change Control Program
CAPA Program
Deviation and Investigation Program
Complaint Handling
Risk Management
Internal Audits
Supplier Qualification Program
Annual Product Reviews

FDA & Regulatory Compliance

Lead FDA inspection readiness efforts.
Act as primary QA representative during FDA inspections, customer audits, and regulatory interactions.
Prepare and coordinate responses to FDA Form 483 observations and Warning Letters if required.
Maintain compliance with:
21 CFR Parts 210 & 211
503B Outsourcing Facility requirements
USP <797>, <800>, and applicable guidance
Data Integrity requirements
Sterility Assurance principles

Manufacturing Quality Oversight

Review and approve:
Batch Production Records
Master Batch Records
Validation Protocols and Reports
Environmental Monitoring Reports
Product Release Documentation
Ensure quality oversight of sterile manufacturing operations.
Partner with Operations, Microbiology, and QC Laboratory teams to resolve quality issues.

Validation & Qualification

Oversee:
Process Validation
Media Fills
Cleaning Validation
Equipment Qualification (IQ/OQ/PQ)
Computer System Validation
Stability Programs

Continuous Improvement

Analyze quality metrics and trends.
Drive improvements in manufacturing quality, compliance, and operational efficiency.
Lead root cause investigations and effectiveness checks.

QualificationsRequired

Bachelor's degree in Pharmacy, Chemistry, Biology, Microbiology, Engineering, or related scientific field.
Minimum 10 years of pharmaceutical quality experience.
Minimum 5 years of leadership experience managing QA teams.
Strong experience in sterile pharmaceutical manufacturing.
Extensive knowledge of:
FDA cGMP regulations (21 CFR Parts 210 & 211)
503B Outsourcing Facilities
Quality Systems and Risk Management
CAPA and Change Control Programs
Batch Record Review and Product Release
Demonstrated success during FDA inspections and regulatory audits.

Preferred

Experience in an FDA-registered 503B Outsourcing Facility.
Experience responding to FDA Form 483 observations.
Analytical Lab expereince including HPLC
Experience supporting Warning Letter remediation programs.
ASQ Certified Quality Auditor (CQA) or Certified Quality Manager (CQM).
Advanced degree (MS, PharmD, MBA, or PhD).

Desired Skills

Strong leadership and people management skills.
Excellent technical writing and SOP development abilities.
Exceptional investigation and root cause analysis skills.
Strong project management capabilities.
Ability to influence cross-functional teams.
Excellent verbal and written communication skills.

Compensation & Benefits

Highly competitive salary based on experience.
Annual performance bonus.
Relocation assistance available.
H-1B transfer sponsorship available for exceptional candidates.
Medical, dental, and vision benefits.
Paid time off and company holidays.
Professional development opportunities.

Why Join Us?

Join a rapidly growing FDA-registered 503B outsourcing facility.
Lead quality department that directly impact patient safety.
Work alongside experienced pharmaceutical manufacturing professionals.
Opportunity to build and strengthen a world-class Quality Management System.
Significant career growth and leadership opportunities.

Pay: $100,000.00 - $145,000.00 per year

Benefits:

Dental insurance
Health insurance
Paid time off
Relocation assistance

Application Question(s):

Do you have 5 years of working in the Pharmaceutical company as a Quality Director?

Experience:

working at 503b facility?: 3 years (Required)
working with FDA and dealing with 483: 3 years (Required)

Work Location: In person

Quick Apply

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hplc jobs in san antonio, tx

Director of Quality

Analytical Chemist

Quality Control Scientist III

Quality Supervisor, Nights

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