Senior QA Specialist - St Petersburg, United States - Catalent Inc

Description

I. Department Overview:

The Quality Assurance Department is responsible for providing leadership and support to the Catalent St. Petersburg site. The Department has the responsibility for Quality aspects related to Quality Systems, Finished Product Batch Release, and Change Control.

II. Basic Function:

This position is responsible for managing and documenting events/discrepancies associated with either product or process as well as managing/writing any investigations that may be a result of those events; processing and investigating customer/consumer product complaints; preparing annual product reviews; tracking, trending and follow-up of the CAPA programs. Interacts directly with the manufacturing personnel and is responsible for maintaining a high-quality environment within the manufacturing area by overseeing and ensuring compliance with current Good Manufacturing Practices and Standard Operating Procedures through the periodic inspections and monitoring of process controls in all applicable areas of the manufacturing operation. The Senior QA Specialist will assist in organizing and prioritizing the activities and schedule for the QA Specialists. The role is responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions. Furthermore, this position will participate in the internal audit program, customer audits and may assist with Supplier Audits/Certification programs.

III. Specific Activities, and Responsibilities:

• Is a first point of escalation for QA Specialists.
• Assist in organizing and prioritizing the activities and schedule for the QA Specialists.
• Provides feedback to QA Supervisor and Manager on performance of QA Specialists.
• Responsible for actively identifying compliance enhancements/improvements and leading project to deliver solutions.
• Collaborates with management and supervisory personnel from operations, quality control and quality assurance to resolve problems affecting product quality; collaboration includes rating, investigating and following up with operators for non-conformance issues and working jointly towards resolution.
• Provide guidance and plan of action to the manufacturing floor when production events occur as defined by SOP and lead cross functional team to classify events and deviations of non-compliant issues according to procedures as defined by SOPs.
• Prepare complaint investigation reports and work closely with others on site events to verify scope of investigations, assure root cause analysis and batch impact assessment are adequate, and recommend corrective actions to prevent deviation recurrence; ensure on time closure.
• May author other types of quality system documents as directed or assigned by QA management.
• Liaise with customers to ensure customer requirements are satisfied.
• Facilitate CAPA commitments and Effectiveness Checks, including initiation, tracking, trending, and closure.
• Prepare annual product reports and ensure on time closure.
• Author/compile monthly, quarterly and annual summaries and metrics, including DRB (Deviation Review Board) presentation.
• Effective communication with Quality Assurance Supervisor and Manager regarding status of daily work.
• Serve as administrator (or back-up) to quality systems as assigned (Documentum, TrackWise, ComplianceWire) including coordination and implementation of site support of corporate initiatives.
• Other duties as required in support of Catalent Pharma Solutions high performance, such as but not limited to, assisting site management in driving and enforcing cGMP's, mentoring other individuals within the compliance organization, participating in internal assessments, routine compliance and CAPA review board meetings including follow-up actions and facilitate and conduct training.

IV. Knowledge Requirements:

• Bachelor's Degree in science or Engineering required (Chemistry, Microbiology or Biology preferred)
• Minimum of 3 to 5 years of related experience in QA pharmaceutical manufacturing and/or manufacturing pharmaceutical operation.
• Prior experience working with investigation writing, including root cause analysis and report writing a must.
• Prior experience with preparing annual product reviews preferred.

Knowledge/Skill Requirements:

• Proven ability to multi-task and demonstrate diplomatic skills.
• Ability to lead others
• Skilled at leading groups (eg Kaizen events or other improvement initiatives)
• Proficient English verbal and written communication skills to convey and receive ideas and instructions with those from within and outside the organization.
• Ability to effectively present information and respond to questions from peers, management, suppliers and customers.
• Strong organizational, analytical, and investigative skills, including ability to solve problems with minimal guidance.
• Proficient to advance skills in Microsoft Office applications (Word, Excel, PowerPoint and Access)
• Working knowledge of cGMPs and/or OSHA regulations
• Motivated, self-started, team player.

Physical/Mental Requirements:

Ability to work effectively under pressure to meet deadlines. Individual may be required to sit, stand, walk regularly and occasionally lift to 15 pounds; no lifting greater than 44.09 pounds without assistance. Be accessible to manufacturing floor and office staff and to use required office equipment. Vision requirements include to have 20/30 vision with or without corrective lenses, read written documents and frequent use of a computer monitor.

Individual's primary Workstation is in the office area, where the noise level is low.

To perform this job successfully, an individual must be able to perform each duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

This job description reflects the general duties of the job but is not a detailed description of all duties which may be inherent to this position. Catalent may assign reasonably related additional duties to individual employees, consistent with company policy.

Why You Should Join Catalent

• Competitive medical benefits and 401K
• 19 days of PTO + 8 Paid Holidays
• Dynamic, fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

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 (see below) 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.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond- it is a fraudulent request. Please forward such requests to (see below) for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.