Co-op - Pharmaceutical Technology

Validation Rochester, Michigan


Description

Job Summary - a concise overview of the job

Perform modification and review of master batch records and manufacturing material specification documents. Create protocols and execute line trials, engineering studies, and cleaning studies. Initiate change records and oversee process improvement initiative projects, and assist in deviation investigations. Obtains knowledge and demonstrates ability to comply with Good Manufacturing Practices and company procedures. Develops and maintains cooperative cross-functional relationships with peers and leadership in Quality, Operations, Packaging Engineering, and Supply Chain to meet plant objectives. In partnership with the site leaders sponsors a quality and compliance focused site culture which embraces RFT (right first time) and CI (continuous improvement) expectations.

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.

Co-Op, Pharmaceutical Technology at Rochester, MI manufacturing supports daily activities of the Pharmaceutical Technology department.

 

Equipment dependent on area focus, may include: formulation vessels (sterile and non-sterile), lab equipment (pH, DO, Temperature), scales, automatic filter integrity testers, Isolators, Washers, Depyrogenation Tunnels, Vial/Syringe/Bottle Fillers, Cappers, Lyophilizers, Terminal Sterilizers, Sterilizers, Inspection equipment (manual, semi-automated, automated).

 

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

Accountability

Responsibilities

% of Time

Operations

§  Creates protocols and executes line trials, engineering studies, and cleaning studies.

§  Compiles study data and completes final reports.

§  Creates/modifies batch record and specification documents.  

§  Initiates change records and oversees process improvement initiative projects.

§  Assists in deviation investigations.

60%

Compliance

§  Understands & adheres to good documentation practices (GDP)

§  Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control.

§  Initiates work orders for equipment and facility repairs/modifications when necessary.

§  Complies with training of batch records, SOP's, and cGMP's, and maintains documentation.

§  Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions.

20%

Leadership

§  Troubleshoots or resolves issues impeding department objectives/deliverable.

§  Consistently communicates. Keeps manager/director informed of project statuses; elevates as needed.

§  Participates in creating an atmosphere of team effort & open communication.

20%

Total

100%

 

Qualifications

Education & Experience

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

Education

§  Required- High School Diploma, and enrolled in a program for a B.A. /B.S. Degree in Science, Engineering, Business or related field or required experience.

§  Desired – B.A. or B.S. Engineering or Science degree program with interest in Manufacturing environments and product development/validation/process improvement.

Experience

§  Required – not applicable

§  Desired – Previous Co-Op experience.


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.

§  Knowledge of MS Office Suite and general computer-based application

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.

To perform the job successfully, an individual should demonstrate the following competencies:

§  Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.

§  Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.

§  Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.

§  Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.

§  Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals. Completes tasks on time or notifies appropriate person with an alternate plan.

§  Technical Skills - Assesses own strengths and weaknesses; Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.

§  Interpersonal Skills - Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others' ideas and tries new things.

§  Written Communication - Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs and intended audience; Presents numerical data effectively; Able to read and interpret written information.

§  Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed

§  Analytical - Synthesizes complex or diverse information; Collects and researches data; Uses intuition and experience to complement data; Designs work flows and procedures

§  Oral Communication - Speaks clearly and persuasively in positive or negative situations; listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Participates in meetings.

§  Initiative -Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.

§  Problem Solving -Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Uses reason even when dealing with emotional topics.

§  Motivation - Sets and achieves challenging goals; Demonstrates persistence and overcomes obstacles; Measures self against standard of excellence; Takes calculated risks to accomplish goals.

§  Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Organizes or schedules other people and their tasks; Develops realistic action plans.

§  Adaptability -Adapts to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation; Able to deal with frequent change, delays, or unexpected events.

Physical & Work Requirements

Physical & mental requirements     e.g. lift 40 pounds, walk across plant/warehouse, business travel (% of time), driving as part of work responsibilities, etc.

§  Routine entry into a manufacturing environment that requires garbing in and out of controlled areas; may include environmentally controlled areas up to ISO Grade 5.

§  Stand, Walk, Sit, Talk and/or Hear

§  Occasionally required to reach with hands and arms and stoop, kneel, crouch, or crawl.

§  Specific vision abilities required by this job include close vision

§  Frequently working near or exposed to moving mechanical parts

§  The noise level is moderate

§  Occasional exposure to fumes, airborne particles, toxic or caustic chemicals

§  Work environment is a production/manufacturing plant