Qualitest Pharmaceuticals, Inc.
Chestnut Ridge, NY, United States
Job Summary -
a concise overview of the job and the expected results
Performs functions relating to the processing of drug products, ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). This is a Lead role, is considered a process expert, and is a Certified Trainer of other Operators. Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. Applies skills and knowledge to recognize process issues and to increase efficiency, throughput and quality. Proactively identifies and resolves complex problems where considerable judgment is required in choosing among multiple options. Troubleshoots process issues and, as a team member, analyzes root causes and makes recommendations. Understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, participates in the debrief to understand the reasons why and what needs to be corrected moving forward. Responsible for the safe and efficient execution of job duties.
All incumbents are responsible for following applicable Division & Company policies and procedures.
Scope of Authority
- span of control
(work unit, site, department, division, etc.), monetary value of budget/spend authority
( capital, operating, etc.), P&L responsibility, etc.
Manufacturing Operations work unit at the sites listed above
- key outcomes/deliverables, the major responsibilities, and % of time
% of Time
§ Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing, potent compound, etc. Meets requirements for use of manufacturing equipment and other commonly used equipment per SOPs.
§ Executes written SOPs to ensure the purity of materials involved in the manufacturing process.
§ Monitors process to ensure schedule is met within standards.
§ Communicates production schedules (with supervisor) to other Operators.
§ Conducts final audit of batch records prior to going to Quality. Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOPs.
§ Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production.
§ May clean manufacturing equipment and facilities according to established SOPs.
§ Executes machine change-overs from batch to batch.
§ Completes a variety of assignments independently based on established procedures.
§ Identifies process improvements that drive increased efficiency, throughput and quality.
§ May sample batches, including validation batches, for quality testing.
§ Executes required in-process product quality checks and documents accurately.
§ With Master Clean/Surface Clean certification, releases rooms to be master and/or surface cleaned.
§ Understands and runs processes to meet the assigned schedules and standards/routers; when this is not achieved, participates in the debriefing session to understand the reasons why and what needs to be corrected moving forward.
§ Completes documentation associated with manufacturing processes (e.g. batch record and logbooks) with detail and accuracy.
§ Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets.
§ Verifies the manufacturing process on BPR in an accurate and timely manner.
§ Provides status updates and operational challenges on status boards.
§ Proactively identifies and troubleshoots process issues. Analyzes root causes, makes recommendations and aids in process improvements.
§ Troubleshoot downtime.
§ May lead or participate in continuous improvement projects.
Safety & Compliance
§ Carries out processing/manufacturing activities safely, as required, on a daily basis.
§ Follows all safety and compliance procedures and participates in required training.
§ Adheres to all cGMP compliance/regulatory mandates and quality requirements.
§ Participate in safety teams, start-up discussions, incident debriefs, etc.
§ Ensures compliance with SOPs, Policies and Procedures as required by the Company and regulatory agencies.
§ Maintains, a clean, organized, work area.
§ Regularly provides mentoring and training to other operators and feedback to the supervisor.
§ May be qualified as a trainer for all training requirements, including company required and machine-specific training.
Teamwork & Collaboration
§ Demonstrates leadership to the team by influencing desired outcomes.
§ Consistently delivers excellent collaboration and communication within the team and across work units.
§ Interacts with cross-functional colleagues and external contacts including individuals representing external vendors and suppliers.
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
§ HS diploma and 4-6 years of Pharmaceutical Manufacturing Operator experience and advanced certification in assigned area, as required or proficiency demonstrated in competencies as required.
§ Forklift certification is required for certain jobs.
Proficiency in a body of information required for the job
e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.
§ Fully knowledgeable of cGMPs.
§ Has thorough knowledge and skills in the processes/product types noted below.
§ Has a wide range of technical skills and operational knowledge.
§ Understands the practical applications to problems and situations ordinarily encountered.
Often referred to as “competencies”, leadership attributes, skills, abilities or behaviors that may be enterprise, functional or job specific e.g. coaching, negotiation, calibration, technical writing
§ Recognized as a process expert.
§ Ability to manage daily workflow.
§ Qualified in both Weighing and Blending (where applicable) and more than one
of the following manufacturing processes:
§ Potent Compound
§ Compression Set-up Technician
§ May be a certified Trainer of others.
§ Competent in setting up and running machinery.
§ Ability to analyze metrics and troubleshoot downtime in conjunction with specialists.
§ Good attention to detail in order to conduct final audits and reviews.
§ Ability to lead or participate in Continuous Improvement projects.
§ Ability to conduct compliance audits.
§ Basic computer skills.
§ Excellent communication skills.
§ Ability to interact effectively with cross-functional colleagues and external vendors and suppliers.
§ Ability to work in both independent and team environments.
§ Basic math, reading, legible writing skills, and problem solving abilities.
Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.
§ Must be able to stand for long periods of time (up to 12 hour shifts), maneuver at least 50 pounds, climb ladders, wear a respirator and pass associated respirator tests and/or requirements, and be able to wear all required PPE ,including safety glasses, ear plugs, and safety shoes.
§ Dexterity - ability to quickly move your hand, your hand together with your arm, or your two hands to grasp, manipulate, or assemble objects.
§ Vision - ability to see details at close range (within a few feet of the observer).
§ Hearing - ability to detect or tell the differences between sounds that vary in pitch and loudness.
§ Multi-limb Coordination - ability to coordinate two or more limbs (for example, two arms, two legs, or one leg and one arm) while sitting or standing.
The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or m
Qualitest Pharmaceuticals, Inc.
Website : http://www.qualitestrx.com/