Supervisor, QA
Harmans, MD
06+ Months

POSITION SUMMARY
The Supervisor, QA OTF Support is responsible for providing quality oversight for the "QA on the Floor" program in accordance with Catalent policies, standards, procedures and Global cGMP. Functional responsibilities include ensuring manufacturing compliance with applicable procedures and batch records, providing real time review of manufacturing batch record documentation and logbooks, and working with operations on the floor to resolve manufacturing issues. This position is required to be present on the floor for 70% of the day.

KEY RESPONSIBILITIES
Provide oversight of the "QA on the Floor" program.
Supervision of OFT processes and personnel.
Ensure staff are fully trained on all cGMP manufacturing operations and documentation and
adhering to safety guidelines
Build effective teams that apply their diverse skills and perspectives to achieve common
goals.
Drive engagement and create a culture where employees are motivated to do their best.
Oversee daily activity for the group to ensure quality results Performance management for
direct reports.
Drives and owns the "Quality on the Floor" program by facilitating the desired 'way of
working' and a quality culture.
Plans and coordinates the activities of the OTF team to ensure coverage for all manufacturing
activities
Provide QA oversight, technical expertise and leadership across all aspects of product
manufacturing and operations support.
Develop and update relevant procedures.
Monitor, participate and oversee the real time batch record review process, including
escalation of issues while on the floor.
Ensure manufacturing compliance with applicable procedures and batch records.
Review manufacturing shop floor documentation, including logbooks, calibrations etc
Ensure that own and teams KPI's, plans, targets and objectives are effectively monitored and
achieved. Including standard lead-times and supporting the Business goals for e.g. RFT and
OTD/ OTIF
Embrace and actively drive Practical Process Improvements (PPI). Directs quality initiatives
that accomplish continuous improvement and enhance site quality system efficiencies.
Partner with manufacturing and key stakeholders to prioritize projects aligning with the
quality goals and objectives.
The supervisor will have a key role with resolution of quality investigations and CAPAs
Ensure interaction with other shifts
Ensure quality events are captured, investigated and closed appropriately in the Trackwise
system.

POSITION REQUIREMENTS:
Masters' degree in a Scientific, Engineering or Biotech field with 4 - 6 years' experience in
Quality Assurance/Quality Control/Manufacturing within biologics, biopharmaceuticals, or a
regulated industry.
OR
Bachelor's degree in a Scientific, Engineering or Biotech field with 6 - 8 years' experience in
Quality Assurance/Quality Control/Maufacutring within biologics, biopharmaceuticals, or a
regulated industry.
Familiarity with Good Manufacturing Practices (GMPs), 21 CFR Parts 210, 211, biological
regulations per 21 CFR Parts 600s, ICH Guidelines and EU GMPs.
Knowledgeable and/or exposure to biological manufacturing processes including microbial and
cell culture cell banking, fermentation/cell culture, purification and fill/finish.
Have the knowledge, and ability to apply basic scientific and regulatory principles utilized to
solve operational, as well as routine quality tasks.
Familiarity with electronic systems, including developing and producing reports using
Microsoft products. LIMS, Master Control and Trackwise knowledge preferred.
Creative individual with excellent analytical, trouble shooting, and decision-making skills
Ability to quickly learn new and novel manufacturing processes supporting new clients
Able to work in a team setting and independently, under supervision
Creative thinking with the ability to multi-task
Commitment to ongoing professional development
Requires the ability to produce results in a fast-paced environment to meet client deadlines