Job Summary - a concise overview of the job

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).   Follows standard procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing.  Learns to apply skills and knowledge to recognize issues and to increase efficiency, throughput and quality.   Learns, understands and runs processes to meet the assigned standards/routers and fulfills the assigned schedule; when these are not achieved, may participate in the debrief to understand the reasons why and what needs to be corrected moving forward.  Assists in troubleshooting process issues.   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 one site.

Key Accountabilities - key outcomes/deliverables, the major responsibilities, and % of time

Accountability

Responsibilities

% of Time

Manufacturing Process

§  Operates pharmaceutical production machinery and follows the procedures for manufacturing such as weighing, blending, dispensing, mixing, coating, encapsulating, granulating, drying, milling, blending, compressing, etc.   Meets the requirements for use of manufacturing equipment and other commonly used equipment per SOP’s.

§  Executes written SOP’s to ensure the purity of materials involved in the manufacturing process

§  Properly uses all scales, including printouts, zeroing, setting tares, and daily calibration verification per SOP’s

§  Examines manufacturer Product ID Labels, Quality Control release tags, and Batch Production Record to verify issued/staged raw materials can be released for production

§  Learns and performs master cleans/surface cleans of manufacturing equipment and facilities according to established SOPs

§  Executes machine change-overs from batch to batch

§  Requires oversight and double-checking; is typically paired with a Qualified Manufacturing Operator

§  Learns sampling techniques

§  Learns, understands and runs processes to meet the assigned schedule and standards/routers; when this is not achieved, may participate in the debrief to understand the reasons why and what needs to be corrected moving forward

70%

Documentation

§  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

20%

Continuous Improvement

§  Learns to troubleshoot process issues with guidance.   Refers deviations from standard procedure to the supervisor.

§  May participate in Continuous Improvement projects

§  Learns and sustains the 6S process

0-5%

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

§  Participates in safety teams, start-up discussions, incident debriefs, etc.

§  Ensures compliance with SOPs, Policies and Procedures as required by Qualitest and regulatory agencies

continuous

Training

Conforms to all training requirements, including company required and machine-specific training.

10%

Teamwork & Collaboration

Learns the responsibilities of being a team member.  Contributes to team and project success by sharing novel insights.  Collaborates typically within own cross-functional work unit.

continuous

Total

100%

Qualifications

Education & Experience

Minimal acceptable level of education, work experience and  certifications required for the job

HS diploma or equivalent with 0-2 years’ related experience*

* Preferred experience: operations work in any industry, machinery operation, shift work, experience working with quality issues or productivity, military experience, basic mathematical & writing aptitude

Knowledge

Proficiency in a body of information required for the job    

e.g. knowledge of FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, etc.

§  Learns cGMP regulations and processes

Skills

&

Abilities

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 etc.

§  Basic math, writing skills, and problem solving abilities  

§  Ability to learn and perform Master Clean/Surface clean

§  Ability to learn one dedicated process (area of responsibility)

Physical Requirements

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), lift 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

Qualitest is an Equal Opportunity Employer