Apply

Job Type

Full-time

Description

Selkirk Pharma is seeking an experienced, industry tenured professional to be our next Quality Assurance (QA) Operations Manager. This leadership role is primarily responsible for adherence to defined timelines as it relates to the development, support and executions of programs/governing procedures including Quality on-the-floor oversight of manufacturing activities, batch review, deviations, CAPAs, and change controls. This role works closely with operations, facilities, and parallel quality functions.

This individual needs to posses a strong background in pharmaceutical contract manufacturing to bring their expertise to our team. To be successful in this role, one must be able to make sound and timey decisions to support our staff and ensure patient safety is paramount. This is a great position for someone looking for a new challenge in the QA area, wishing to work with a rewarding team and is excited to build systems using their prior knowledge.

This is an on-site, full-time, exempt position, located in Spokane, WA. Selkirk Pharma offers a comprehensive benefits package that includes medical, dental, vision, life, AD&D, and FSA for health and dependent care 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!

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.

Hiring Wage: $125,000 - $155,000 annually

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

Full Wage Range: $155,000 - $186,000 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.

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:

* Works cross functionally with Selkirk Pharma Stakeholders to define scalable processes to support organizational operations and quality needs.

* Develops process map workflows and writes Standard Operating Procedures (SOPs) to support the Selkirk Parma Quality System.

* Provides quality on-the-floor oversight of manufacturing, reviewing documentation, and providing real-time support of operational issues.

* Provides quality decisions that impacts operations, ensuring appropriate escalation.

* Identifies risks and communicate gaps for quality and GMP process/systems.

* Manages daily deviation triage review.

* Develops, implements, and manages CAPA and Deviation Qualification Programs and provides ongoing user support.

* Develops, tracks, and trends departmental KPIs ensuring quality processes are compliant.

* Provides QA review and approval of Manufacturing procedures, work instructions, forms, and templates.

* Authors, reviews and approves Deviations, CAPAs and change controls.

* Collaborates with Manufacturing to resolve equipment and process issues.

* Develops, implements, and manages the on-the-floor QA support of Manufacturing program.

* Develops, implements, and manages the real-time Batch review programs.

* Performs audits of manufacturing and support areas, including in-process batch record review for adherence to internal procedures and Good Documentation Practices.

* Identifies and implements continuous improvement initiatives and participates in site and corporate quality and process improvement initiatives.

* Practices safe work habits and adhere to Selkirk Pharma safety procedures and guidelines.

Requirements

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

* Bachelor's degree in science or relevant field; or an equivalent combination of education and experience.

* Nine (9) years' experience in a Biotech/Pharma cGMP Manufacturing / Quality Operations environment required.

* Two (2) years' experience in leadership/supervisory role; demonstrated leadership skills and experience leading a team/department.

* Extensive knowledge of industry guideline including cGMP and regulatory guidelines (i.e. FDA, EU, ICH, ISO).

* Experience in quality of aseptic processes Grade A through Grade D production areas and knowledge of isolation technology with filling operations experience highly desired.

Computer Skills:

* Proficient in the use of Microsoft Office Suite including: Word, Excel, PowerPoint, and Outlook.

* Experience utilizing QMS software such as Trackwise, Master control, Vevva, EtQ Reliance, etc.

* Working knowledge of Virtual Manufacturing Software, such as ModaES, Master Control, Syncade, Detla V, and Electronic Batch Records preferred.

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.

Salary Description

Hiring Wage: $125,000 - $155,000 annually