QA Packaging Lead (On the Floor) - Operations (Philadelphia, PA)
At AstraZeneca, we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s outstanding skills with those of people from all over the globe.
As the QA OTF Pack Lead, you will be responsible for assuring the quality of licensed and products manufactured at the PA site. This role provides leadership and guidance to a number of functional areas including the PET, Facilities, Training, QC, Supply Chain and other quality departments, and directly supports packaging and supply chain operations.
The Philadelphia, PA site manufactures a life-saving influenza vaccine. Our product is aseptically filled into sprayers for nasal administration. The site consists of two geographic locations - a facility at Red Lion Road in NE Philadelphia has about 140 full-time employees and the Bensalem storage and distribution facility has about 5 employees. The facilities are about 8 miles apart and both are situated close to I-95, the city of Philadelphia, and Philadelphia International Airport. Our product is sold in the US, UK and other countries. Operations continue year round, with the production season being in the summer (typically May – August).
Our site is highly collaborative where we show our Philly pride in all we do. We work closely together, always striving to be better every day. We have a network of employee teams who deliver many kinds of employee engagement activities, from our famous Wingbowl, to inclusion events, a site picnic, community outreach, health and wellness activities, and a green team.
- Responsible for supervising Quality Assurance Specialists and seasonal staff.
- Interprets and implements quality policies, quality systems, and assists in facilitating regulatory compliance inspections.
- Manages the real-time Batch Record Review process
- Provides real time GMP support to other groups
- Performs trend analysis to monitor process and facility performance
- Maintains a high level of understanding of relevant production processes and quality systems
- Performs the QA review and approval of the following GMP documentation as it relates to the processing equipment and facility to which the position is aligned:
- Change Requests
- Quality Investigations (Deviations, Product Complaints)
- Validation Plans, Protocols and Reports
- Standard Operating Procedures
- Collaborates with and influences other Quality professionals across the organization to ensure consistent application and execution of key quality systems
- Collaborates with and influences other PET/assigned area members to facilitate process improvements and risk assessments; benchmarks internal and external QA practices to identify innovative efficient and effective practices
- Stays abreast of evolving regulatory compliance practices and recommends implementation strategies to site leaders
- Role model in the use of lean tools and methodologies.
- BS in biology, chemistry, engineering or related field.
- 7+ years in biopharmaceutical /pharmaceutical industry.
- Minimum 3 years of supervisory managerial experience.
- Ability to independently identify and resolve complex problems through good decision utilizing functional and technical skills.
- Ability to manage conflict and stand alone on issues.
- Ability to provide constructive feedback to staff.
- Recommends modifications to operating policies.
- Graduate degree is desirable.
- Strong experience in pharmaceutical, biotech or medical device packaging or manufacturing
- Lean Manufacturing experience
- Aseptic Manufacturing experience
Next Steps – Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity. If you know someone who would be a great fit, please share this posting with them.
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.