Operations Lead/Supervisor (Swing Shift)

Serán BioScience•Bend, OR

2d•Onsite

About The Position

Support daily activities for the Operations Department and oversee swing shift activities according to established procedures. This position is responsible for ensuring a high level of compliance with internal SOPs and regulatory guidance. The Operations Lead or Supervisor assigned to swing shift will direct the daily workflow of the department, assign tasks to Operations team members, and ensure projects are completed to GMP standards and specifications of SOP with a focus on suite cleaning and material dispensing. Operations Lead or Supervisor is responsible for independent problem solving and expressing good judgement in decision making and knowing when it is appropriate to escalate concerns.

Requirements

Mechanical aptitude
Intermediate math skills
Strong verbal and written communication skills
Strong organization skills and attention to detail
Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside of the company
Accepts feedback from a variety of sources and constructively manages conflict
Proficient math and problem-solving skills
Strong time management skills with ability to meet deadlines
Ability to prioritize and ask for assistance to delegate tasks when appropriate
Ability to focus in a fast-paced environment with shifting priorities
Proficient with Microsoft Office Suite or related software
High school diploma or equivalent
Demonstrates history of leadership abilities
Proficient in Oral Solid Dosage and Spray Dry equipment and GMP processing
Requires a minimum of 2 year of GMP experience
Must be able to lift up to 25 pounds regularly, and up to 55 pounds occasionally
Require ability to work swing shift with the possibility of 12-hour shifts
Must be able to wear a Tyvek suit with PAPR for extended periods of time
Exposure to constant low-level equipment noise, and occasional high-level alarms
Work near heat generating equipment
Must be able to operate a forklift, training provided
Move up and down ladders, kneel, squat and lift from the floor
Move mop above head while cleaning room surfaces
Adheres to consistent and predictable in-person attendance

Nice To Haves

Preference will be given to internal candidates

Responsibilities

Oversee small production team and daily shift activities
Follow strict standard operating procedures (SOPs)
Write and review standard operating procedures
Weighs, measures, subdivides, and disposes of components
Safely handle hazardous materials
Participate in audits or inspections
Inspects and maintains equipment
Draft, review, and approve quality records as technical approver
Subject matter expert for operations
Conduct and attend training activities
Completes documentation, including logbooks and batch production and control records
Works closely and communicates effectively with operations team
Responsibilities may increase in scope to align with company initiatives
Performs other related duties as assigned