Senior Compliance & Laboratory Systems Specialist
Position Summary:
Work Schedule: Monday-Friday 8 AM-4:30 PM; potential to transition to 12-hour shifts in the future
This position is 100% on-site at the Adair site.
The newly launched manufacturing facility on Adair Blvd marks a pivotal expansion of Catalentâs ZydisÂŽ technology, a globally renowned, fast-dissolve oral dosage form that has transformed the lives of millions of patients worldwide. This is your opportunity to join a dedicated team at the forefront of pharmaceutical manufacturing. At Adair, youâll play a vital role in the startup of a site built for innovation and excellence, from installation and qualification to regulatory approval and commercial manufacturing.
Reporting to the Director of Quality, the Senior Compliance & Laboratory Systems Specialist is responsible for ensuring compliance with regulatory standards and internal policies, overseeing electronic laboratory systems, and supporting the companyâs various quality management systems and qualification activities to ensure GMP compliance. The Senior Compliance & Laboratory Systems Specialist serves as a key liaison between Quality Control, IT, Validation and Quality Assurance, ensuring data integrity and system validation across the site.
The Role
Ensure laboratory operations comply with GMP/GLP requirements, current governmentâmandated regulations, and Catalent Global Quality Policies and Standards, while administering user accounts, roles, and system functions for electronic laboratory systems (e.g., LSA).
Oversee laboratory calibration and equipment qualification activities to ensure compliance expectations are met and collaborate with IT and Validation teams to maintain system compliance with 21 CFR Part 11 and data governance requirements.
Participate in and approve data integrity assessments across laboratory and nonâlaboratory systems, identify data integrity risks (DIARP), and support the development of improvement plans, including identifying data and system issues, defining requirements, and recommending enhancements to system functionality and related processes.
Leads, coordinates, and participates in investigations and corrective action identification/ implementation for Deviations & Laboratory investigation reports. Ensures on-time closure of deviations, LIRs and corrective action/preventative action items.
Act as the Quality subject matter expert for the review and approval of SOPs, validation and qualification protocols, summary and trend reports, and change controls to ensure compliance with quality standards, while ensuring Environmental Monitoring (EM), Purified Water (PW) monitoring, and cleaning validation programs fully meet regulatory requirements and established policies and procedures.
Support siteâwide quality improvement initiatives by contributing to project teams to execute key quality projects and drive the continuous improvement of the Quality Management System by leading teams through the implementation of new systems, processes, and ways of working.
Provide support during regulatory and customer audits, ensuring readiness and compliance; Represent laboratory compliance during inspections.
Perform other duties as required.
The Candidate
A bachelor's degree in a relevant field such as Life Sciences, Engineering, Computer Science or a related discipline is required.
5+ years of experience in a Quality Assurance environment, ensuring safety, quality, and productivity is required.
Experience working in pharmaceutical and/or GMP facilities, experience in Laboratory environments is preferred.
Previous experience in Quality Management System & Validation, preferably within the pharmaceutical industry, is highly desirable.
Strong attention to detail and accuracy, with experience generating, reviewing, and approving controlled documents.
Knowledge of laboratory techniques, terminology, equipment, and materials, with handsâon experience using electronic laboratory systems.
Strong understanding of GxP requirements, 21 CFR Part 11, data integrity principles, and system validation.
Excellent interpersonal skills with the ability to work effectively across all levels and functions, and to influence and motivate others to achieve results.
Candidates with non-Canadian credentials must provide an evaluation confirming the Canadian equivalency of the credentials as determined by the Alliance of Credential Evaluation Services of Canada (ACESC) such as WES.
Currently Catalent participates in the Ontario Immigrant Nominee Program (OINP) on a limited basis.
While performing job duties, the employee must be able to communicate effectively, sit for extended periods, and use manual dexterity to operate a computer and office equipment. Occasional standing, walking, reaching, bending, stooping, kneeling, or crouching may be required. Close vision is required. The role may involve exposure to hazardous chemicals; employees are expected to follow all applicable safety procedures.
Pay
The final salary offered to a successful candidate may vary within this range $67,000 â $82,000, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a global employer, and this salary range does not reflect positions that work in other countries.
Why You Should Join Catalent
Comprehensive Benefit Package (Health, Dental, Vision, & Life Insurance)
Group Retirement Savings âRegistered Pension Plan (RPP) with employer contributions
Paid Time Off Programs
Opportunities for professional and personal development & growth including tuition reimbursement
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.Â
personal initiative. dynamic pace. meaningful work.
Visit Catalent Careers to explore career opportunities.
Catalent is an Equal Opportunity Employer and does not discriminate based on any characteristic protected by local law.
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, and confirming your request for an accommodation and include the job number, title and location to DisabilityAccommodations@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local 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.
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