9 ΡΠ°ΡΠΎΠ² Π½Π°Π·Π°Π΄
Quality Control Supervisor (Environmental Monitoring)
ΠΡΡΡ & Π‘ΠΎΠΏΡΠΎΠ²ΠΎΠ΄
ΠΠ»Ρ ΠΌΡΡΡΠ° Ρ ΡΡΠΎΠΉ Π²Π°ΠΊΠ°Π½ΡΠΈΠ΅ΠΉ Π½ΡΠΆΠ΅Π½ Plus
ΠΠΏΠΈΡΠ°Π½ΠΈΠ΅ Π²Π°ΠΊΠ°Π½ΡΠΈΠΈ
Π’Π΅ΠΊΡΡ:
TL;DR
Quality Control Supervisor (Environmental Monitoring) (Biotech): Leading cleanroom environmental monitoring and microbiological testing programs in a cGMP-regulated manufacturing environment with an accent on compliance, investigations, and team coordination. Focus on analyzing environmental trends, driving CAPAs, authoring quality documentation, and supporting audits and regulatory inspections.
Location: On-site in Pearland, Texas, United States. Saturday through Tuesday, 8:00 a.m. to 6:30 p.m. on a 4x10 schedule.
Company
operates globally connected life-sciences manufacturing sites focused on producing medicines and supporting customer therapies.
What you will do
- Lead and coordinate the Quality Control Environmental Monitoring team and supervise personnel through scheduling, coaching, performance management, and development.
- Maintain cleanroom monitoring programs for At Rest and In Operation conditions and coordinate microbiological assays, utility monitoring, and excursion reporting.
- Review testing records, laboratory documentation, and monitoring data for compliance with cGMP requirements and site procedures.
- Develop and improve monitoring programs, sampling plans, procedures, trend reviews, performance metrics, and resource planning.
- Lead environmental excursion investigations and implement corrective and preventive actions.
- Collaborate with manufacturing, Quality Assurance, facilities, and other functions while representing QC Environmental Monitoring during audits and inspections.
Requirements
- Experience in Quality Control within a cGMP-regulated environment.
- Bachelorβs degree in a scientific discipline, preferably Microbiology.
- Experience with cleanroom operations and Environmental Monitoring programs, including required Level 1 and Level 2 gowning experience.
- Strong knowledge of microbiological testing, microorganism identification, environmental monitoring, and aseptic processing.
- Leadership, supervisory, or team management experience and the ability to coordinate team resources.
- Ability to work the Saturday through Tuesday 4x10 on-site schedule; strong investigative, communication, and problem-solving skills.
Nice to have
- Familiarity with SAP, MODA, and TrackWise.
- Previous leadership, supervisory, or team management experience.
Culture & Benefits
- Performance-related bonus.
- Medical, dental, and vision insurance.
- 401(k) matching plan.
- Life insurance and short- and long-term disability insurance.
- Employee assistance programs, paid time off, and a weekend differential.
ΠΡΠ΄ΡΡΠ΅ ΠΎΡΡΠΎΡΠΎΠΆΠ½Ρ: Π΅ΡΠ»ΠΈ ΡΠ°Π±ΠΎΡΠΎΠ΄Π°ΡΠ΅Π»Ρ ΠΏΡΠΎΡΠΈΡ Π²ΠΎΠΉΡΠΈ Π² ΠΈΡ ΡΠΈΡΡΠ΅ΠΌΡ, ΠΈΡΠΏΠΎΠ»ΡΠ·ΡΡ iCloud/Google, ΠΏΡΠΈΡΠ»Π°ΡΡ ΠΊΠΎΠ΄/ΠΏΠ°ΡΠΎΠ»Ρ, Π·Π°ΠΏΡΡΡΠΈΡΡ ΠΊΠΎΠ΄/ΠΠ, Π½Π΅ Π΄Π΅Π»Π°ΠΉΡΠ΅ ΡΡΠΎΠ³ΠΎ - ΡΡΠΎ ΠΌΠΎΡΠ΅Π½Π½ΠΈΠΊΠΈ. ΠΠ±ΡΠ·Π°ΡΠ΅Π»ΡΠ½ΠΎ ΠΆΠΌΠΈΡΠ΅ "ΠΠΎΠΆΠ°Π»ΠΎΠ²Π°ΡΡΡΡ" ΠΈΠ»ΠΈ ΠΏΠΈΡΠΈΡΠ΅ Π² ΠΏΠΎΠ΄Π΄Π΅ΡΠΆΠΊΡ. ΠΠΎΠ΄ΡΠΎΠ±Π½Π΅Π΅ Π² Π³Π°ΠΉΠ΄Π΅ β
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