Par Health · 20 hours ago
Operations Support Technical Writer
Rochester, MI
Full-time
Onsite
Mid, Senior Level
5+ years expPar Health is a healthcare company committed to improving lives through quality and safety. The Operations Support Technical Writer is responsible for fostering a quality and compliance-focused culture, driving timely resolution between departments, and executing operational changes through effective technical writing and project management.
HealthcareManufacturingPharmaceuticalHealth CareMedical
Responsibilities
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
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)
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
Qualification
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
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
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
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
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
Preferred
Pharmaceutical/quality operations including direct quality management system participation
Existing experience writing/executing investigations, or general technical writing
Knowledge of aseptic processing
Company
Par Health
We’re Par Health — the essential pharmaceutical company. We believe great healthcare is built on getting the essentials right.
1001-5000 employees
Funding
Current Stage
Late StageRecent News
EIN Presswire
2025-04-21
Company data provided by crunchbase