Job Description

Operations Support Technical Writer

The Operations Support Technical Writer, with support of Site Leadership, sponsors a quality and compliance focused culture, embracing RFT (Right the First Time) and CI (Continuous Improvement) expectations. The Operation Support Technical Writer is expected to be knowledgeable in multiple operational areas: material handling, dispensing, compounding, filling, inspection, and packaging operations with a high degree of knowledge and experience in Quality Management Systems such as change management, deviation investigation, and CAPA. The Operations Support Technical Writer will be liaison between departments to drive timely resolution, expected to result in an improved compliance focused culture and manufacturing waste stream reduction. Role relies heavily on technical writing and investigative skills with potential to build into operational project execution in progressive roles.

Scope of Authority (work unit, site, department, division, etc.), monetary value of budget/spend authority (capital, operating, etc.), P&L responsibility, etc.

Rochester, MI manufacturing plant - Cross Departmental.

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

Accountability

Responsibilities

% of Time

Quality / Operations

• Leads and/or participates in investigations; writes supporting reports/protocols and minor/major level investigations utilizing root cause analysis tools.
• Emphasis on corrective resolution and preventive measures. Professionally supports cross departmental teams ranging from operators to management level professionals.
• Executes operational changes/projects, thru change control management; utilizes the Change Management system to plan pre/post implementation action items.

85%

Quality / Compliance

• Develops training materials related to corrective and preventive actions
• Performs review of procedures during investigations with the ability to identify gaps/misalignment with current practice.
• Executes updates to Standard Operating Procedures (SOPs) and Master Batch Records (MBRs).

15%

Leadership

• Communicates with operators, operations management, and quality.
• Ensures best practices, processes, and procedures are defined, documented, and implemented company-wide that satisfy quality systems requirements

Continuous

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 or related field OR
• 5-years experience in pharmaceutical/quality operations including direct quality management system participation

Experience

• Desired: pharmaceutical/quality operations including direct quality management system participation
• Existing experience writing/executing investigations, or general technical writing

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 and understanding of manufacturing processes, facilities and processing equipment, as well as cGMPs, SOPs and regulatory requirements. Knowledge of aseptic processing preferred.
• Strong computer/systems skills using Quality Management Systems, MS Office Suite, and/or Enterprise Resource tools (i.e., Trackwise, ComplainceWire, Maximo, Veeva or similar).
• Strong technical writing and presentation skills.

Skills & Abilities

• 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.
• Resilience - Deals effectively with pressure, remains optimistic and persistent even under adversity. Recovers quickly from set backs.
• Project Management Develops project plans; Coordinates projects; Communicates changes and progress; Completes projects on time and budget; Manages project team activities
• Change Management Develops workable implementation plans; Communicates changes effectively; Builds commitment and overcomes resistance; Prepares and supports those affected by change; Monitors transition and evaluates results
• Quality Management Looks for ways to improve and promote quality; Demonstrates accuracy and thoroughness
• Innovation - Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others' attention
• 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.
• 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.

Physical Requirements

Physical & mental requirements e.g. lift 40 pounds, walk across plant/warehouse, business travel (5% of time), driving as part of work responsibilities, etc.

• Routine entry into a manufacturing environment that requires garbing in and out of environmentally controlled areas up to ISO Grade 5.
• Capable of working remotely.
• 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

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.

EEO Statement: At Endo, we firmly believe in the principles of equal employment opportunity and strive to create an atmosphere where all employees, regardless of their race, color, creed, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability (including pregnancy), age, or military or veteran status, feel valued, respected, and empowered. Our commitment to EEO extends to every aspect of employment, including recruitment, hiring, training, promotions, compensation, benefits, transfers, terminations, and all other employment practices. We are dedicated to ensuring that all employment decisions are based on qualifications, skills, and merit.

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