Analytical Quality Assurance Specialist

JOB SUMMARY

The Analytical Quality Assurance Specialist will be the primary point of contact for a given product/program. This position is expected to support multiple programs as needed and support the coordination of the quality systems. Work is highly independent.

DUTIES AND RESPONSIBILITIES

Ensuring that adequate QA support is provided for the cross functional IPT meetings and Customer teleconferences Communicating the status of QA related items to the IPT Team including batch release and investigation status Taking an active role providing, as appropriate, guidance within the approved systems and procedures as it related to GMP production and release of products, some of this guidance may be required outside of the typical working schedule (off shift) Taking an active role in planning and execution of action items related to support of production and product release, including document control and production record review activities Managing the release of products to support subsequent production and release of product to customer within the approved systems and procedures. Managing change controls in support of production and release activities Review and/or conduct of investigations for deviations in production and testing (VAR, MNCRs, OOS/OOT investigations, QCRs) Ensuring process validation and qualification requirements are established in approved protocols and results of the validation and qualifications are adequately presented in approved reports Responsible for facility audits of the respective manufacturing facilities at the start of each campaign and periodically while long running campaigns are active. Adhere to all company SHE policies and procedures, actively participate in hazard identification and environmental risk reduction, and report all incidents, nonconformities, and potential hazards to management to support a safe, healthy, and environmentally responsible workplace. May perform other duties as assigned.

EDUCATION AND EXPERIENCE

Bachelors degree in an appropriate science. Masters Preferred. 10-14 years of related technical experience or equivalent combination of education and experience.

COMPETENCIES/SKILLS

Strong attention to detail. Ability to work in a face paced, team-oriented environment. Ability to act with a sense of urgency, while maintaining accuracy and data integrity

CERTIFICATION/LICENSES

Not applicable

WORKING CONDITIONS

Participates in production support including nights, weekends, and holidays. This role may involve work in laboratory or manufacturing environments with potential exposure to chemicals or other regulated substances. As a condition of employment, incumbents may be required to participate in employer-provided medical surveillance programs in accordance with applicable regulatory requirements and company policy.