Qc Drug Product Operations Supervisor

4 weeks ago

College Station, United States Fujifilm Full time

Overview:
College Station, Texas may be a small, university town, but the lively cultural scene and local amenities make it a great place for families as well as those who want the ease of small-town life and the convenience of living close to the vibrant pulse of big cities. Eighty-seven percent of Texas' population lives within a 180-mile radius, so we are in the center of it all in Texas. And our site is nestled in the hub of innovation, representing a source of pride for the area.

Other responsibilities may include but are not limited to staff hiring, supervision, training, discipline and performing annual review assessments; preparing and reporting out monthly metrics for all worked performed within the department; ensuring all equipment is in a state of GMP readiness; writing and reviewing SOPs, verification protocols and reports.

External US:
**Primary Responsibilities**:

- Provide clear and understandable direction and goals for the team.
- Interpret applicable quality and regulatory requirements and develop associated policies for the laboratories operations.
- Manage operating costs for the outsourced testing and laboratory supplies.
- Develop and enhance the Company Visual Inspection program. Establish, monitor, and investigate Action and Alert limit excursions and implement corrective and preventive actions, as needed.
- Oversee and guide investigations regarding invalid and out-of-specification results.
- Assure the implementation and effectiveness of appropriate and timely corrective actions.
- Work closely with Quality Assurance and other departments to continuously improve the effectiveness of the Quality Management Team.
- Work collaboratively with manufacturing and product development teams to improve quality, increase efficiency, solve problems, generate cost savings, and provide new product support.
- Interface with current and potential clients.
- Interface with investigators during both internal and external inspections and audits.
- Evaluate external audit observations and develop responses and oversight for related action plans.
- Adapt, develop, or review and approve procedures, protocols, and reports.
- Follow and enforce all established laboratory, regulatory, safety, and environmental procedures.
- Adhere to and enforce the standards of quality ruled by current GMP and the company Quality Policies and site SOPs.
- Identify and assist in deviation investigations and report possible preventative and corrective actions.
- Knowledge base and demonstrated experience in USP 790 / 1790 / USP 787 / USP 788/ USP 789/USP 1207/ USP 631
- Familiar with qualification of personnel for visual inspection and perform training and assessment of personnel performance.
- Review and approve associated documentation (Sample Plans, Product Specification, SOPs etc.)
- Must follow good documentation practices in all aspects and phases of the work; provide reports for review in a timely manner; work with other lab personnel on projects and participate in (OOS) Out-of-Specification and failure investigations.
- Perform other duties as assigned.

**_
Required Skills & Abilities:_**
- Demonstrated skills to lead and mentor a group cohesively, effectively and with compliance mindset.
- Demonstrated ability to follow proper safety measures and policies while working in the lab.
- Develop staff to maximize contributions to team and company.
- Must have excellent organizational, written communications and oral communication skills.
- Ability to explain information appropriately based on the audience (i.e., technical concepts to a non-technical audience).
- Ability to follow safety procedures outlined in the Chemical Hygiene Plan.
- Computer proficiency required, Knowledge of MS Office (Word, Excel, Outlook, PowerPoint).
- Detail oriented and accurate.
- Ability to multi-task and prioritize work assignments with little supervision.
- Role model for company core values of trust, delighting our customers, Gemba, and Genki.

**Working Conditions & Physical Requirements**:
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to:

- Experience prolonged standing, some bending, stooping, and stretching.
- Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.
- Ability to sit for long periods to work on a computer.
- Potential for exposure to chemicals, gases, fumes, odors, dusts, and other hazardous materials.
- Ability to wear personal protective equipment including but not limited to safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt), cleanroom (ISO 8 to ISO 5) gowning materi

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