The Quality Assurance Department is responsible for
providing Leadership and Quality Assurance Management
support within each of the Business Units at Catalent’s
St. Petersburg site. The Department has the
responsibility for Quality aspects related to Quality
Systems, Finished Product Batch Release, and Change
Control. Each Business Unit is comprised of a Quality
Assurance Manager and a Business Unit Manager who
liaison in support of designated customers and products.
II. Basic Function:
(A brief statement describing the basic purpose of the
This position is responsible for the overall Quality
Assurance review of all technical documents including
but not limited to: a) process improvement projects and
Research & Development Projects; b) all equipment
IQ/OQ/PQ documents regarding equipment, utilities, and
computer systems; c) all product process validation and
cleaning validation documents; and d) all Preventive
Maintenance and Calibration work order requirements for
III. Specific Activities, and Responsibilities:
(A concise list of the key responsibilities of the job.)
and manufacturing improvements throughout the design
- Provide QA Technical support during the development
phase, technical transfers and routine production.
and technical concerns to determine trends affecting
- Ability to investigate and analyze technical reports
future designs, production activities.
analysis to eliminate future problems.
- Provide QA Technical recommendations based on trend
Services/Validation/Engineering project meetings to
- Participates in R&D/Technical
provide Quality Assurance input with respect to
compliance to cGMP requirements.
- Reviews and approves technical documents, such as:
- Technical Services Protocols and Reports.
- Process Validation Protocols and Reports.
- Cleaning Validation Protocols and Reports.
- IQ/OQ/PQ Protocols and Reports.
- Change Control, as it pertains to the above
regarding the compliance and adequacy of the documents
- Provides feedback to the appropriate department (i.e.
reviewed as it pertains to cGMPs, site SOPs, and FDA/MCA
Education or Equivalent: (Minimum required to perform
- Approve documents as designated by Supervisor/Manager
or Biology preferred) required or equivalent;
- Bachelors Degree in Science (Chemistry, Microbiology
and/or training and/or equivalent combination of
- A minimum of five to ten years related experience
education and experience in the QA pharmaceutical
- Prior experience working with validation or technical
- Proven ability to multi-task and demonstrate
- Must possess excellent English verbal and written
- Intermediate to proficient skills in Microsoft Office
Knowledge/Skills Requirements: (Unique knowledge skills
or problem-solving requirements.)
- Prior quality assurance experience is required.
- Working knowledge of cGMPs and/or OSHA regulations
- Certified Quality Engineer is a plus.
- Excellent oral and written communication skills a
- Proficient in Microsoft Word, Excel, Access and Power
within the organization.
- Ability to speak effectively and present before groups
determine impact to processes and systems in place.
- Ability to review and evaluate technical documents and
- Ability to solve problems with minimal guidance.
- Ability to review and write protocols, reports, and
to questions from peers, management, suppliers and
- Ability to effectively present information and respond
- Motivated, self-started, team player.
Ability to work effectively under pressure to meet
deadlines. Individual may be required to sit, stand,
walk regularly and occasionally lift 0-15 pounds. Be
accessible to manufacturing floor and office staff and
to use required office equipment. Specific vision
requirements include reading of written documents and
use of computer monitor screen frequently.
Individual’s primary workstation is located in the
office area, where the noise level is low.
Req. Code : 2881
Division/Department : Catalent Pharma Solutions -
Exemption : Exempt
Shift/Hours : First Shift (Day)
% of Travel Required : None
Offer Relocation : No
Catalent Pharma Solutions - 2 years ago