Production Supervisor

Endo Pharmaceuticals Irvine, CA
Job Summary - a concise overview of the job

The Supervisor, Production, under general supervision, directs and oversees the manufacturing process operation. The Supervisor ensures that all phases of manufacturing activity are performed in a safe manner and in compliance with the cGMP and Standard Operating Procedures (SOPs). This position also ensures that Company and government compliance are adhered to.

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.

Generic Manufacturing Operations at Irvine, CA site (produces solid dosing tablets with extended release)

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

Accountability

Responsibilities

% of Time

Documentation

§ Performs on-going cGMP and safety training to department process operators.

§ Assures that manufacturing operations are performed in compliance with batch records, SOP's and cGMP's.

§ Revises batch records and SOP's as required.

§ Batch Record Review.

20%

Work Schedule

§ Supervise and coordinates the manufacturing work schedule to meet production requirements.

§ Assigns and delegates work assignment responsibilities to subordinate hourly personnel.

§ Reviews and approves time sheets for hourly employees.

§ Ordering of some production operating supplies, gowning, processing supplies, tooling's etc.

30%

Training

§ Performs responsibilities associated with the department training, problem resolution, work assignment delegation and attendance tracking; applies effective implementation of employee disciplinary corrective action programs; conducts performance evaluations.

30%

Compliance

§ Ensure compliance with all Company policies and procedures.

§ Keep the Area Manager informed of all current process issues.

10%

Training

§ Improves the efficiency of the operation by analyzing and correcting production equipment and processing issues.

10%

Total

100%

Qualifications

Education & Experience

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

§ Bachelor Degree from an accredited college required.

§ 3 to 5 years' experience in a management position required.

§ Minimum of 5 years' experience in a production/operations position in the pharmaceutical or other regulated industry is required.

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 current Good Manufacturing Practices (cGMP), Food and Drug Administration (FDA), and other regulatory requirements.

§ Understanding of manufacturing processes, equipment procedure and systems, and the principals of safety, worker compensation, OSHA, and related principals/practices.

§ Principal of mathematical and statistical calculations.

§ Standard Operating Procedures for equipment operations including safety rules and regulations.

§ Implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources.

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.

§ Proficiency in Microsoft Office software (Word, Excel and PowerPoint) preferred.

§ Proficiency in JDEdwards (JDE) software.

§ Proficiency in technical writing for investigation writing purposes.

§ Effective oral and written communication skills.

§ Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution.

§ Principles of supervision and / or related trainings.

§ 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.

§ 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.

§ 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.

§ Delegation - Delegates work assignments; Matches the responsibility to the person; Gives authority to work independently; Sets expectations and monitors delegated activities; Provides recognition for results.

§ Leadership - Exhibits confidence in self and others; Inspires and motivates others to perform well; effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.

§ Managing People - Includes staff in planning, decision-making, facilitating and process improvement; Takes responsibility for subordinates' activities; Makes self-available to staff; Provides regular performance feedback; Develops subordinates' skills and encourages growth; Solicits and applies customer feedback (internal and external); Fosters quality focus in others; Improves processes, products and services.; Continually works to improve supervisory skills.

§ Quality Management - Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness.

§ Diversity - Demonstrates knowledge of EEO policy; Shows respect and sensitivity for cultural differences; educates others on the value of diversity; promotes a harassment-free environment; Builds a diverse workforce.

§ Ethics - Treats people with respect; Keeps commitments; inspires the trust of others; Works with integrity and ethically; Upholds organizational values.

§ 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 Requirements

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

§ Extended periods of walking and standing.

§ Moderate noise levels at times.

§ Occasionally lift and/or move up to 25 pounds.

§ Occasionally exposed to fumes or airborne particles.

§ The noise level in the work environment is usually moderate.