Jubilant HollisterStier LLC, a well-established member of the business community in Spokane, Washington, provides a complete range of services to support the pharmaceutical and biopharmaceutical industries. The Allergy business is a worldwide leader in the manufacture of allergenic extracts, targeted primarily at treating allergies and asthma. Jubilant HollisterStier is also a nationally recognized contract manufacturer of sterile injectable vials, and lyophilized products. Jubilant HollisterStier is a proud member of the Jubilant Pharma family.
Our Promise: Caring, Sharing, Growing
We will, with the utmost care for the environment and society, continue to enhance value for our customers and stakeholders by providing innovative products and economically efficient solutions' through growth, cost effectiveness and wise investment of resources.
Shift: Monday - Thursday Nights - 6pm - 4:30am
Job Description:
The QA Compliance Associate/ Sr. Associate provides support to the company Deviations, Corrective and Preventive Action (CAPA) program through a complete assessment of Root Cause Analysis (RCA) of Deviations and vendor complaints/issues. Assure product compliance and product safety. Ensure accurate and timely data entry and oversight of the company Quality Systems related to Deviations, CAPA and vendor complaint activities. Essential responsibilities include:
- Review Deviations, investigations and CAPAs to ensure accuracy, consistency and compliance with applicable SOPs/Policies, Specifications and related guidelines/regulations.
- Accountable for facilitating Deviation investigation/resolution, assessing product impact and for completing/writing final assessment/lot disposition for QA Management and Client review and approval.
- Enters data into database in support of the corporate RCA and CAPA activities.
- Provide oversight of investigational RCA group activities including preparation of meeting agenda, providing necessary information to meeting participants, publishing of meeting minutes, and follow-up on agreed upon activities and tasks.
- Interface with management and responsible individuals to assure task completion on or before established due dates.
- Responsible for supporting quality systems, processes and procedures (e.g. Deviation, CAPA, Vendor complaint, etc...) to assure compliance and product quality and safety.
- Accountable for assisting the QA and applicable Department Management to ensure and follow up on implementation of corrective actions that stem from deviations, audit or regulatory inspections.
- Provide Deviation and CAPA metrics as needed in support of management review of system data.
- Work extensively with appropriate department(s) to gain an understanding of the production/analytical testing process and other applicable process to ensure capture of appropriate details and conclusions in the investigation or corrective action documents.
Sr. Associate (In addition to above)
- Provide investigation training as needed to the Quality Unit and other departments to ensure that investigations are handled consistently throughout the company.
- Speak to assigned deviations during regulatory and client audits.
- Act as the QAC Lead Associate when requested by the QAC SUPERVISOR (in the absence of the QAC Lead Associate) Perform special assignments as directed by the supervisor.
Qualifications:
Associate:
- Associates Degree in Biology, Chemistry or related field required. OR 5 years of experience may be used in a lieu of an Associate's degree. Bachelor's Degree in a science field desired.
- Minimum 2 years of experience required. Bachelor's degree can be used in lieu of experience.
- Pharmaceutical and FDA regulated industry experience desired.
- Experience with technical writing, investigations, CAPA systems, building & manufacturing processes/systems, and QC analysis is highly desired.
- Knowledge of cGMPs desired.
Sr. Associate:
- Associates Degree in Biology, Chemistry or related field required. Bachelor's Degree in a science field desired.
- Minimum 5 years of related experience required with an Associate's Degree. Minimum of 2 years related experience required with a Bachelor degree.
- Pharmaceutical and FDA Regulated Experience required.
- Experience with technical writing, investigations, CAPA system, building and manufacturing processes/systems, QA operations systems, and QC analysis is required.
- Knowledge of cGMPs required.
- Must have demonstrated effective verbal and written communication with all levels of staff.
- Must have demonstrated strong interpersonal skills and conflict management.
- Must have ability to prioritize investigations based on impact to the facility and release of batches.
- Ability to lift 30 pounds unassisted.
- Prolonged sitting required.
Both Associate and Sr. Associate:
- Direct or supporting aseptic manufacturing experience in bio/pharma industry desired.
- Microsoft Word & Excel required.
- Sologic Certificate desired.
- Basic exchange of information required.
- Managing conflict and influencing outcomes desired.
- Provides analysis, diagnosis or production tasks which noticeably impact end results.
Shift: Monday - Thursday Nights - 6pm - 4:30am
Compensation:
This is an on-site, full-time position located in Spokane, WA.
- Hiring Wage:
- Associate: $30.01 - $35.30
- Sr. Associate: $67,725 - $93,500 depending on experience, with opportunity for growth, promotion and annual raises. See full list of benefits below for our complete compensation package.
- This position is eligible for a shift premium of $2.00 per hour worked between 3pm and 11pm, and $2.50 per hour worked between 11pm and 7:30am.
- Full Wage Range:
- Associate: $30.01 to $40.59 per hour
- Sr. Associate: $67,725 - $102,000 annually.
Midpoint and above is reserved for employees who have longevity with Jubilant HollisterStier and consistently exhibit outstanding performance over a period of time in the role
- Medical, Dental, Vision, Flexible Spending and Health Savings Accounts
- Life, AD&D, Short and Long Term Disability
- 401(k) with company match
- Generous paid time off plan
- Employee Assistance Program
Optional Benefits:
- Voluntary Life and AD&D for employee & family
- Supplemental Medical coverage (Critical Illness, Hospital Indemnity and Accident coverages)
- Pet Insurance
- ID Theft Protection
- Perk Spot Discount Program
Unlock your potential with Jubilant HollisterStier! If you're seeking a dynamic and rewarding career, we welcome your application today!
https://jubilantcareer.jubl.com/
*Please click on the Spokane, Wa. Link*
Jubilant HollisterStier is an EEO/AA Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.
If you require assistance applying for a position, please contact our HR Department at:
Human.Resources@jubl.com
Jubilant HollisterStier LLC
paid time off, long term disability, 401(k)
Nov 09, 2024