Description

If you have a passion for precision, quality and the drive to produce life-saving medication, this is the opportunity you have been waiting for. Selkirk Pharma is seeking a Manufacturing Operator to join our team. We are looking for a true team player, who is always willing to collaborate and support colleagues. In this dynamic role, the Operator will work in a cleanroom environment and follow cGMP batch records and SOPs to manufacture sterile injectable products. This role supports projects in conjunction with other GMP Manufacturing personnel (Leads, Supervisors, Managers). This role prepares suites for manufacturing operation and operates in a safe and compliant manner.

Selkirk Pharma offers a comprehensive benefits package that includes medical, dental, vision, life, AD&D, and FSA for health and dependent care, HSA option and 401k. Selkirk Pharma offers vacation, sick, and parental leave. Please read more on the job tasks and requirements below. Qualified candidates should apply today!

This role performs job tasks in an aseptic environment, which requires good personal hygiene and operators to wear cleanroom apparel, including scrubs, smocks, shoe covers, hair covers, gloves and facility-dedicated footwear. The following is not permitted in the aseptic space: fingernail polish, false nails, fake eyelashes, hair extensions, hair gels, use of perfume or cologne.

This is a full-time position, located in Spokane, WA. The facility has Monday-Friday operations, and schedule for this role is 4 10's (40 hours : 10 hour shifts, 4 working days), with the occasional need to flex start/end times to support business needs. 

Hiring Wage: $20.00 – 23.50 per hour. See full list of benefits below for our complete compensation package. 

Full Wage Range: $20.00 - $27.95 per hour. Midpoint and above is reserved for employees who have longevity with Selkirk and consistently exhibit outstanding performance over a period of time in the role.

About us:

Selkirk Pharma is a new aseptic fill/finish contract manufacturer of sterile injectable products, located in Spokane, Washington. Every member of our highly dedicated team plays a critical and visible role in helping to manufacture and deliver life-saving drugs to patients. Our shared values of sincerity, gratitude, enthusiasm, humility and team guides us and enables us to deliver upon our vision of a world where safe and effective medication is accessible for every patient, every time it’s needed. At Selkirk, we enjoy our work, appreciate where we live and are grateful for the opportunity to be part of an industry that makes a difference in people’s lives.

RESPONSIBILITIES: To perform this job successfully, an individual must be able to satisfactorily perform each of the essential duties/responsibilities listed below. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential duties/responsibilities of this job. The essential functions of the position include but are not limited to the following:

• Adhere to Parenteral Safety policies and procedures, contribute to a safe work environment.
• Set up, operate, monitor & control equipment, systems & processes associated with isolator.
• Perform cleaning and sanitization of aseptic manufacturing areas.
• Adhere to standard operating procedures and current Good Manufacturing Practices (GMP) to ensure quality of product.
• Adhere to aseptic technique practices to ensure all manufacturing environmental standards are upheld.
• Execute production recipes, check-in equipment, and perform material movements using automated computer software applications (ERP and EBR systems)
• Clean and sanitize materials into classified environments
• Review & author SOP’s & other documents, as required
• Work effectively and efficiently in a team-oriented environment to ensure maximum and high-quality output
• Perform aseptic processes in a controlled or cleanroom environment.
• Request materials, setup, preparation, final filtration, and formulation, filling vials inside a Grade A isolator with an automated filling machine
• Assist other departments with the qualification of manufacturing equipment in support of facility start up.
• Participate in the execution of all phases and facets of drug product formulation, fill and visual inspection.
• Operate relevant department equipment in an appropriate manner and in accordance with requirements.
• Ensure all equipment and facilities are maintained.
• Maintain a clean and safe work environment.
• Complete all associated documentation in compliance with requirements.
• Perform basic inventory transactions.
• Communicate process needs and progress to co-workers and supervisor.
• Escalate events and concerns to supervisor.

Requirements

Education and/or Experience: To perform this job successfully, an individual must have:

• High school diploma or equivalent required.
• Associates Degree in Business Management or Science-related field preferred.
• cGMP manufacturing knowledge or 1-year related experience in a government-regulated industry preferred.
• Basic mechanical skills and experience operating automated equipment preferred.

Computer Skills:

• Proficient in the use of Microsoft Office Suite including Word, Excel, and Outlook.
• Experience utilizing manufacturing ERP system is a plus.
• Ability to learn and utilize electronic batch record (EBR) software.

Certifications, Licenses, Registrations

• Forklift certification or ability to obtain certification not more than 3 months from date of hire or as soon as training is available and deemed necessary.

 FULL-TIME BENEFITS:

• Medical (two medical plans offered)-
• PLAN 1: Company pays 90% of employee premiums; 75% of dependent premiums.
• PLAN 2: HDHP- Company pays 100% of employee premiums; 100% of dependent premiums.
• Dental and Vision: Company pays 90% of employee premiums; 75% of dependent premiums.
• Company provided Basic Life & AD&D Insurance
• Voluntary Life & AD&D available for an employee to add additional coverage for themselves and dependents
• Voluntary Long-Term Disability available
• Employee Assistance Plan
• Flexible Spending Account: Health Care Reimbursement & Dependent Care Reimbursement
• Stock Options
• Vacation available– up to 160 hours per year, pro-rated based on hire date
• Sick leave available– up to 52 hours per year, pro-rated based on hire date. Additional leave based on overtime for non-exempt employees
• Bereavement Leave – 5 days per event
• Emergency Leave – 2 days per year, pro-rated based on hire date
• Parental Leave / Maternity and Paternity Leave – 160 hours per occurrence
• Jury Duty – up to 10 days per event
• Paid Company Holidays (major holidays)
• Cell Phone Stipend – $10 per month
• 401k Plan: Company Safe Harbor Matching Contributions equal to 100% of your contribution up to 3% and 50% of your contributions from 3-5%

HOW TO APPLY:

If you meet our qualifications and you are motivated by working in a highly energetic, collaborative environment, we invite you to apply for this position.

We invite you to apply for this position no matter what your identity is; you will be welcome here. All qualified individuals will receive consideration for employment. We are an equal opportunity employer.

Selkirk does not engage with recruitment services. All resumes / cover letters / applications / etc. sent to Selkirk are considered a direct application without representation. Selkirk does not compensate for recruitment services.