Supervisor, Bulk Manufacturing

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Supervisor, Bulk Manufacturing

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locations

Rochester, Michigan

time type

Full time

posted on

Posted 3 Days Ago

job requisition id

R001012

Responsible for daily coordination and execution of working schedules of people and equipment in Bulk Formulation. Responsible for supervising hourly union operators that perform dispensing and formulation of a variety of drug and biological products, including Par branded, development & generic as well as contract customer products while meeting department quality, safety, delivery and productivity objectives. Reviews and releases batch record documentation; completes yield transactions or component returns. Ensures people and processes comply with Good Manufacturing Practices, company procedures, and the union contract. Modifies department standard operating procedures, investigates excursions, and executes change controls to support business and quality objectives. Establishes & maintains cooperative cross-functional relationships with peers in Quality, Sterile Operations, Process Development, 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. 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.
Supervisor of Bulk Formulation and Drug & Chemical operations at Rochester, MI manufacturing plant; Supervises 8-10 hourly workers.

Security-sensitive (highly sensitive) position under the Controlled Substance Abuse Practice.

Significant equipment includes: formulation vessels (sterile and non-sterile), lab equipment (pH, DO, Temperature), scales, and automatic filter integrity testers.
Key Accountabilities

- key

outcomes/deliverables,

the major responsibilities, and % of time
Accountability
Responsibilities
% of Time
Operations
Oversees hourly operators in execution of daily work; assures operators comply with validated parameters and standard operating procedures.
Responsible for schedule adherence; participates in scheduling meetings with the objectives of increased resource

utilization.
Responsive to changes in daily workflow and schedule; determines needs & redeploys resources and/or overtime to achieve delivery & customer service commitments; adapts to ebb/flow of production process including changes due to unplanned maintenance or events requiring investigation.
Ensure all equipment is working properly.
Completes final batch record reviews for Bulk formulation and Drug & Chemical.
Completes in-process checks & verifications in alignment with Standard Operating Procedures.
20%
Compliance
Understands & adheres to good documentation practices (GDP)
Executes Quality Management System assignments (CAPA, Deviation, Change Control, Standard Operating Procedures etc.) to on-time closure.
Obtains knowledge and executes assignments in QMS areas: deviation management and/or change control.
Conducts investigations for cause, determines corrective action, and impact; writes reports & assures timely closure.
Initiates & executes change control assignments in support of continuous improvement initiatives for equipment, documentation, or processes.
Initiates and approves maximo work orders
Creates, reviews and conducts operator training programs & assures operator training is conducted on SOPs, cGMP, and safety.
Assure and assist classroom and hands on training for batch records, SOP's, and cGMP's, and maintain proper documentation to ensure compliance.
Follow and comply with company Safety policies and OSHA Regulations
Participates in development & maintenance of a safe manufacturing environment. Establishes methods in compliance with regulatory, plant, and corporate policies. Participates in safety meetings, investigates accidents, and takes appropriate corrective action to eliminate hazardous conditions.
25%
Supervisory
Reports production updates & schedule changes to team and/or at daily Huddle/SMART meetings.
Assures hourly operators comply with all procedures, GMP regulations, safety, and contract obligations; provides constructive operator feedback
Assigns manpower; Initiates documentation of violations and disciplinary action with operators as required.
Requests equipment and facility repairs, or modifications.
Understands & complies with Union Agreement.
25%
Leadership
Reviews operational performance; executes improvement opportunities.
Counsels, trains, & develops union colleagues for efficient performance; creates an atmosphere of team effort & open communication.
Consistently communicate, follow and enforce SOPs and company policies and guidelines set forth in the employee handbook.
Troubleshoots or resolves issues impeding department daily/weekly deliverables; proactively demonstrates the ownership to achieve.
Interfaces with suppliers of equipment or products and area consultants/experts
Supports CMO audits or regulatory agency inspections.
30%
Total
100%
Qualifications
Education & Experience
Minimal acceptable level of education, work experience and certifications required for the job
Education
Required- B.A. /B.S. Degree in Science, Business or related field or significant experience.
Desired- B.A. /B.S. Degree in Science
Experience
Required None
Desired 1-3 years in Pharmaceutical Packaging, Operation or Quality Department
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
Ability to acquire knowledge/use of Enterprise Resource Planning tools (JD Edwards); Quality MS (Management Systems), Document MS, Learning MS (Trackwise, Master Control, and ComplianceWire respectively); and MS Office Suite; Kronos, Maximo
Able to understand & comply with all current state, federal and local standards and regulations, e.g., cGMP, OSHA, EEOC, EPA, FDA and DEA
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:
For internal candidates: meets or exceeds expectations as follows:
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
To perform the job successfully AND progressively achieve, an individual should demonstrate the following competencies:
Design

- Generates creative solutions; Translates concepts and information into images; Uses feedback to modify designs; Applies design principles; Demonstrates attention to detail.
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.
Professionalism

-

Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts

responsibility/accountability

for own actions; Follows through on commitments.
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.
Resilience

-

Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
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.
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
May be required to be cleanroom gown qualified
Disclaimer:

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 modify such duties as required.

About Us

Be the change you wish to see. Come join us We want the best and brightest people at Endo to help us achieve our mission to develop life-enhancing products through focused execution. Our 3,000+ global team members are united by the important role that we play in delivering healthcare and are dedicated to supporting each other as we work to bring the best treatments forward.

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