Pharmaceutical QA Specialist

4 weeks ago


El Segundo, United States Fladger Associates Full time

Responsibilities:

- Excellent employment opportunity for a Sr QA Specialist in the El Segundo, CA area.
- The company is seeking a Senior Specialist of Quality Operations responsible for Product Disposition.
- This position will participate in Quality activities to ensure compliance with applicable quality objectives and regulatory requirements.
- This position is located at our El Segundo, CA site and report into the Associate Director of Quality Operations.
- Position is Day Shift including weekends and requires onsite presence.
- Perform Product Disposition and Lot Closure. Includes commercial and clinical products.
- Review batch-related documentation and ensure resolution of issues to release product
- Review batch-related shipment documentation to ensure product shipment remained in control
- Provide QA oversight and review of deviations tied to lots.
- Ensure deviations are properly initiated, investigated and resolved in accordance with established disposition timelines.
- Provide QA oversight and (limited) approval of CAPAs.
- Ensures that associated CAPAs are initiated and resolved.
- Provide QA oversight and approval of change records.
- Ensures that change records are initiated and resolved.
- Support and participate in investigations, including batch record review.
- Ensure process control measures are in place and followed in product manufacturing
- Maintain metrics related to product disposition in support of the Management Review
- Generate and update procedures, forms and other documents
- As assigned, manage and provide QA oversight for other processes, including training, warehouse/inventory, redose, new product introductions, etc.
- Generate and report data for management
- Maintain production (finite), disposition, and team schedules
- Represent Disposition or QA Ops at plant and multi-site scheduling meetings
- Provide QA representation on projects and at team meetings
- Provide QA representation at multi-site disposition meetings
- Support and participate in inspections and audits

**Experience**:

- Master’s Degree and 5+ years of experience in GMP environment OR
- Bachelor’s Degree and 7+ years of experience in GMP environment OR
- High School Degree and 11+ years of experience in GMP environment

Preferred Qualifications
- Bachelor’s degree in the Biological Sciences or related field and minimum of 7 years progressive experience in a Pharmaceutical, Biotech, or Biologics Operation, or equivalent education/work experience.
- Ability to understand risk and provide phase-appropriate appropriate decisions
- Ability to effectively negotiate and build collaboration amongst individuals
- Good interpersonal skills
- Strong written communication skills
- Strong analytical skills
- Comfortable in a fast-paced small company environment and operate with mínimal direction
- Ability to adjust workload based upon rapidly changing priorities

**Job Type**: Contract

Pay: $35.00 - $41.00 per hour

**Benefits**:

- 401(k)
- 401(k) matching
- Dental insurance
- Health insurance
- Life insurance
- Paid time off
- Vision insurance

Schedule:

- Day shift
- Monday to Friday

Work setting:

- In-person

**Experience**:

- pharmaceutical company: 5 years (required)

Shift availability:

- Day Shift (preferred)

Ability to Commute:

- El Segundo, CA 90245 (required)

Ability to Relocate:

- El Segundo, CA 90245: Relocate before starting work (required)

Work Location: In person



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