Under general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians / assistants. Comply with divisional and site Environmental Health and Safety requirements.
• Daily supervision of quality assurance associates includes direction of daily activities as necessary, resolution of issues with quality assurance and internal, external clients.
• Prepare associates performance reviews for assigned associates. Provide performance reviews in both oral and written form to associates.
• Review and release of batch documentation.
• Review and approval of quality events such as deviations, investigations, document control and change control.
• Quality assurance review and approval of validation documents (IQ/OQ/PQ).
• Quality assurance review of construction/facilities maintenance activities plans.
• Author quality assurance SOPs.
• Identify deviations/investigations during manufacturing or packaging process and provide direction as to appropriate course of action.
• Lead or assist in GMP training of associates.
• Train new associates as required.
• Perform packaging audits.
• Meet deadlines according to agreed timeframes and communicate adjustments as needed.
• Clear understanding of related SOPs, cGMPs necessary to accomplish daily tasks.
• Mentor and develop direct reports.
• Adhere to company policies.
• Attend assigned meetings.
Education and Experience: Bachelor’s degree in a scientific discipline with 5+ years of Quality Assurance experience in a GMP environment.
LEAN, Six Sigma or ASQ certification preferred.
• Excellent verbal and written communication skills.
• Lead by example according to Catalent's values and culture
• Highly organized and attentive to detail.
• Ability to lead teams and influence stakeholders.
Recognizes and address unmet needs within department.
Identify and drive quality improvement initiatives.
Collaborate with peers and demonstrate leadership capabilities in a matrix environment.
Able to sit for extended periods
Ability to conduct audits within testing laboratories
Ability to use a computer
Ability to lift approximately 15lbs
Specific vision requirements including reading of written documents
Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
Collaborative and inclusive
Professional Office Setting
The QA department responsible for packaging is a fast-paced, but generally quiet office-based environment. Dress-code is business-casual unless certain situations call for business-professional attire.
Catalent Pharma Solutions is the leading global provider of advanced delivery technologies and development solutions for drugs, biologics and consumer health products. With over 80 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent is headquartered in Somerset, N.J. For more information, visit www.catalent.com
More products. Better treatments. Reliably supplied.™
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status.
If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives:
Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.