Reporting to the Quality Supervisor, the Plant Quality Compliance Specialist is responsible for the following primary functions:

• Sampling, inspecting, and release of raw materials, components, and labeling materials.
• Real-time monitoring, line release, AQL inspection to support daily powder production activities.
• Pulls appropriate finished product samples as per established schedule for retention & stability testing purposes.   Enters sample information into sample administration logbook and database.
• Performs pre- and post-production batch record reviews.
• Executes product/material labelling and system transactions consistent with disposition status.
• Maintenance of sample retention program.
• The QA technician coordinates with production and QC lab to ensure proper support is provided to ensure materials are released in a timely manner.
• Assist Quality Supervisor in maintaining Quality Systems, such as Document Control, Investigations, CAPA, Change Control and Complaints Systems
• All work is performed maintaining compliance with cGMPs and following standard operating procedures.

Role Responsibilities

• Coordinates sampling of incoming raw materials and provides samples to QC labs for testing and release
• Inspects and releases labeling/packaging materials
• Requires individual to gown and wear proper PPE appropriately in the respective production rooms
• Performs monitoring of non-sterile powder filling operations which includes line clearance and release
• Document work in master production records, logbooks, and data sheets as applicable
• Perform status change in QAD for release of raw materials, components and labels
• Participates in investigations of deviations, environmental notifications or complaints as applicable
• Prepares paperwork and labels for samples and respective specification sheets with QC lab samples for testing
• Prepares and revises standard operation procedures (SOPs)
• Perform line clearance and line release for manufacturing
• Perform product hold/product disposition, as well as physical placement of materials into/out of quarantine as needed
• Initiate Material Destruction Orders, perform related system transactions and complete related documentation accordingly.
• Oversees sample retention program
• Performs all housekeeping and cleaning activities in the sample testing area, as necessary.
• Assists in the preparation for Health Authority inspections and audits and provides support to their execution and follow-up.
• Review of quality related documents.
• Assists in collection of data for Annual Product Reviews.
• Assists in data collection and trending of Quality metrics.
• Participates in production, quality or safety continuous improvement projects
• Ability to lift, push, pull and carry up to 50lbs; requires a combination of walking around the facility along with sedentary work
• Ensure all work is carried out in compliance with Good Manufacturing Practices (cGMP) and company safety policies
• Other duties as assigned

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role

FOSTERING COLLABORATION/TEAMWORK- is the ability to work jointly with others or together especially in an intellectual endeavor; the ability and desire to work cooperatively with others on a team; as a team leader, the ability to demonstrate interest, skill, and success in getting groups to learn to work together. Builds partnerships for global performance.  Respects others.

INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it.

THOROUGHNESS/DETAIL ORIENTED – Ensuring that one’s own and others’ work and information are complete and accurate; carefully preparing for meetings and presentations following up with others to ensure that agreements and commitments have been fulfilled.

ATTENDANCE/PUNCTUALITY (non-exempts & hourly) – Meeting expectations requires that the employee regularly reports for work on time, prepared to start his/her assigned duties at the appointed time.  Report-for-duty time is defined as readiness to perform the first assigned task at the scheduled start of a shift and employee does not leave assigned post early, works through the end of work hours.    Employee leaves and returns from scheduled breaks and lunch at designated times.

Requirements

Essential:

• 2-3 years’ experience in manufacturing environment and relevant experience in a regulated Pharmaceutical industry including Quality Systems, Quality Assurance, Quality Control

• Knowledge of cGMP, Quality Systems (CAPA, Investigations, Complaints, Change Control), manufacturing and packaging processes required.
• Bachelor's degree in sciences or related field preferred

• Excellent documentation skills
• Technologically savvy, familiar with MS office application
• Self-started with ability to prioritize tasks
• Strong collaboration skills with other departments

• Ability to communicate effectively defending quality initiatives and compliance.

• Must be able to manage competing priorities
• Excellent command of the English language; written and orally

Desirable:

• Pharmaceutical manufacturing experience
  

About Bimeda

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

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