Sr. QA Specialist (C-Shift)
Company: Disability Solutions
Location: Saint Petersburg
Posted on: April 22, 2024
Job 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:Education or Equivalent:
- 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 (e.g. 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.Work Environment: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
ProcessesCatalent 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 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 . 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 spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Port Charlotte , Sr. QA Specialist (C-Shift), Other , Saint Petersburg, Florida
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