AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas - immunology, oncology, neuroscience, and eye care - and products and services in our Allergan Aesthetics portfolio.
The Quality Assurance Supervisor I is responsible for the organization, administration, and supervision of Quality Assurance employees within the manufacturing operations. Responsible for properly overseeing the day-to-day operations by prioritizing shop floor presence and receiving guidance and direction from more senior leaders. This includes delivering high levels of customer service, ensuring quality of product and services, complying with all regulatory requirements, achieving desired financial performance including cost reductions, and building a culture of high performance for the team.
Responsibilities
- Responsible for leading a high performing team and prioritizing presence with the team.
- Leads a team in the Quality function & is responsible for hiring, setting performance expectations, driving team engagement, providing continuous & on-time performance feedback, developing staff, assisting team in problem-solving, & handling of employee matters.
- Provide Quality support on the manufacturing shop floor
- Responsible for supporting Operations efforts in meeting established production schedule
- Partner with Operations employees to document exception documents, including re-inspection and resolve other outstanding plant quality/compliance issues
- Propose changes update, author, and implement departmental procedures consistent with objectives of simplification and process efficiencies/improvements which ensure ongoing compliance
- Investigate QC hold, quarantine and reject for materials not meeting standards, ensure the initiation of exception documentation and oversee the implementation of any corrective action
- Responsible for the review and approval of Procedures and Change Requests
- Assist/serve/provide feedback on continuous improvement initiatives/teams
- Reviews and releases batch records. May serve as a backup when the Quality Manager is unavailable. Performs other tasks/projects as assigned.
Significant Work Activities
- Frequent to continuous computer usage (greater or equal to 50% of the workday) is required
Qualifications
- Bachelor's degree in sciences or engineering.
- 2+ years of experience in a manufacturing production environment.
- Experience in regulated pharmaceutical, biotechnology or medical device industry is preferred.
- Thorough knowledge of Quality Assurance operations including safety, application of FDA and GMP regulations.
- Direct manufacturing and regulatory interface experience is preferred.
- Effective problem-solving, decision-making, teamwork, influence, negotiation, and conflict resolution skills required
- Ability to work cross-functionally and coordinate work both within the department and with other departments.
- Ability to identify, communicate, and follow through to completion and assist in the development of necessary corrective action plans to resolve problems with supervision
- Demonstrated strong leadership skills and ability to foster an inclusive environment
- Experience managing SAP, Sample Manager or LIMS software is highly desired.
The selected candidate must be available to work on an extended second shift and weekends.
Additional Information
- The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position.
- We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- This job is eligible to participate in our short-term incentive programs.
- This job is eligible to participate in our long-term incentive programs
AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.