(Onsite) Operations Support Technical Writer

Why Us?

At Par Health, we believe great healthcare is built on getting the essentials right. We’re looking for passionate, talented individuals who share our commitment to improving lives. With 4,000+ team members worldwide, we lead with pride and purpose—prioritizing quality and safety while fostering a culture of continuous improvement, accountability, and teamwork. Elevating the Essentials isn’t just our tagline, it’s the higher standard we live by every day.

Job Description Summary

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.

**Remote work is not available for this position; onsite presence is required.**

Job Description

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.

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

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.

• Professionalism - Approaches others in a tactful manner; React