COMPANY DESCRIPTION:

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.

Starting /Hiring Wage: 25.49 - 31.23

See full list of benefits below for our complete compensation package.

Full Wage Range: 25.49 - 36.96 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.

POSITION SUMMARY:

This position is primarily responsible for performing inspections and testing of incoming resources. This role leads others in best-in-class techniques and practices while adhering to regulations and reporting any non-conformance.

KEY or ESSENTIAL FUNCTIONS:
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:

• Provides knowledge and expertise (subject matter expert - SME) for the department.
• Conducts inspection activities to determine product acceptance of components while assuring compliance with written procedures:
• Performs sampling, visual, dimensional, and functional inspections and/or testing across all incoming materials, excipients, and products.
• Performs accurate mechanical, physical, dimensional, and visual inspection of incoming raw materials, components, and sub-assemblies as per Inspection Plans and Specification Requirements.
• Uses all applicable tools and equipment to ensure conformance with design or specifications.
• Reviews device history records e.g., CoA’s, specifications, etc. to ensure compliance to established procedures and acceptance criteria.
• Uses aseptic techniques and skills while performing job duties.
• Performs job functions in compliance with established work instructions and adherence with SOPs.
• Reads and interprets specifications and/or component prints.
• Ensures calibration and maintenance is performed on inspection equipment.
• Reports any Non-Conforming Materials/Processes.
• Works with the Quality Unit and Supply Chain to resolve issues in materials received from suppliers.
• Assists with facility qualification activities as required.
• Identifies and handles deviations per standard operating procedures. Assists in investigations as necessary.
• Remains up to date on industry practices, trends, and regulations while sharing information with colleagues and drive change where warranted.
• Drafts and reviews SOPs, Specifications, Policies, and other documents as required.
• Develops strong working relationships throughout all levels of the organization.

SECONDARY FUNCTIONS:

These functions do not affect the essence of the job and could be reassigned to another individual for a short period of time. Secondary functions of this position include:

• Substitutes into supervisory function for limited durations.
• Participates ad hoc as a quality assurance representative, and other related duties as assigned to meet Selkirk Pharma objectives.
• Assist Filled Vial Inspection team as needed.
• Performs all other duties as necessary or assigned.

FULL-TIME BENEFITS:

• Medical, 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%

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

• 5 years related experience in the pharmaceutical industry.
• Associate degree in relative field, or High School diploma with 2 years equivalent experience
• Knowledge and experience in 21 CFR Part 211. Knowledge of FDA cGMP, GAMP 5, Eudralex Volume 4 Annex 1, USP, EP, and other industry related guidance documents.
• Pattern of demonstrated initiative to work and communicate efficiently and effectively to accomplish tasks.

Computer Skills:

• Proficient in the use of Microsoft Office Suite including Word, Excel, PowerPoint, and Outlook.
• Experience utilizing LIMS software, ERP software and QMS software desired.
• Working knowledge of MODA-EM and MODA-ES software desired.

PHYSICAL REQUIREMENTS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is

• Regularly required to sit, stand, climb, walk, grasp, reach, talk, or hear.
• Frequently required to stoop/crouch, lift 20 lbs., pull/push 50 lbs., or carry 20 lbs.
• Specific vision abilities required by this job include close vision, distance vision, peripheral vision, depth perception and ability to adjust focus with or without corrective lenses. Employees must be able to differentiate between colors (no color blindness).

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.