• Cost: Demonstrate a cost conscience mindset and reduce waste in order to deliver profitability.

• Reporting: Ensure that all relevant information relating to all functional responsibilities and activities are tracked, captured

and forwarded in due time to the management.

• Quality: Ensure all activities are executed following quality and regulatory standards. Promote a quality mindset and quality

excellence approach to all activities.

• EHS: Ensure all activities are executed including EHS standards and promotes a safety culture.

• Act as change agent: Personal responsibility for supporting the value stream way of working at Customer facility in Marietta.

Ensure that communication flows cross-functionally and that a purely functional focus (silo) is not allowed to develop. Deal

positively with change, demonstrating the ability to maintain high personal performance levels as the organization evolves.

Is also a positive influence on others' ability to adapt to change.

• Service to other Areas/Departments/Teams: Actively apply customer relationship management to provide pro-active response

to customer needs. Maintain, develop and work in close relationship with all defined customers of the role.

• Decision-making will directly impact disposition of product lots, material/equipment/area tag-out or quarantine actions, and

validation status of production lines. This position will provide consistent compliant approach to assessing failures,

recommending and implementing corrective measures, and will have direct influence on the disposition of materials.

• Accuracy of on-line QA review and approval of production records.

• This position is integral to the identification and resolution of deviations in products and processes in the Marietta operations.

Problem resolution must be prompt and effective directed toward lasting improvements to the operations.

• Will identify the root cause for problems and recommend effective improvements.

• Priorities can change very quickly due to new business opportunity or new sales projection. High adaptability required and

ability to keep motivation in team when priority changes.

CANDIDATE SPECIFICATIONS:

• B.S or B.A in a technical discipline, preferrably Microbiology, Biology/Virology, Biochemistry, Chemistry or Pharmacy.

Degree in other discipline if sufficient technical depth has been achieved from profressional experience.

• Minimum of 3 years pharmaceutical experience in Quality Assurance preferrably in Biologics Secondary Manufacturing or 3

years as a manufacturing technician in a Biologics Secondary Manufacturing operation.

• Working knowledge of pharmaceutical facilities, equipment and systems. Including a technical understanding of industry

and science practices related to the business in order to apply knowledge to daily activities.

• Demonstrated problem solving and investigational skills.

• Training and work experience in root cause analysis tools (Isikawa) and statistical analysis (TQM, SAS) required.

• Knowledge of GMP’s, NIH Guidelines, FDA and other regulatory agency requirements sufficent to apply to quality

operations and compliance. Working knowledge of validation principles, quality systems and FDA regulations.

• The ability to commuincate both verbally and in writing with all levels both inside and outside of the oragniziation. The

ability to clearly write QA documentation as necessitated by regulatory agancies an internal policy.

• Ability to establish and maintain working relationships with Secondary Manufacturing staff and the abiliy to analyize data

and implement changes.

• Able to interact with peers, subordinate and senior personnel in multidisciplinary environment including engineering, facility

operations, validation, production and QC. Ability to work in a high complex matrix environment.

• Able to prioritize and decide appropriate course of actions and to effectively implementing decisions.

• Ability to facilitate and generate the exchange of ideas to resolve problems, prioritize solutions, select optimal solutions and

implement decisions.

• Intermediate computer skills required.

• Stay current on developments in the field and Customer-Bio Standards.

• Maintain attention to detail, while completing multiple or repetitive tasks.

• Demonstrate a serious commitment to accuracy and quality while meeting goals or deadlines.

• Maintain a high level of integrity while balancing multiple priorities and responsibilities.