Qa Compliance Associate/Sr. Associate

2-5 years

Not Disclosed

Remote, USA

10 Jan. 27, 2025

Job Description

Job Type: Full Time Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Job Title: QA Compliance Associate/Sr. Associate (Days, Mon - Fri)
Location: Spokane, WA

Company Overview:
Jubilant HollisterStier LLC is a prominent player in the pharmaceutical and biopharmaceutical industries, offering a complete range of services. We are a global leader in the manufacture of allergenic extracts for treating allergies and asthma and a recognized contract manufacturer of sterile injectable vials and lyophilized products. We are part of the Jubilant Pharma family, committed to providing high-quality, innovative products to improve lives globally.

Job Description:
Jubilant HollisterStier is seeking a motivated and detail-oriented QA Compliance Associate/Sr. Associate to support our Deviations, Corrective and Preventive Action (CAPA) program. This position will be responsible for ensuring product compliance and safety, maintaining accurate records, and supporting Quality Systems related to Deviations, CAPA, and vendor complaints.

Key Responsibilities:

Deviation & CAPA Management:
- Review deviations, investigations, and CAPAs to ensure accuracy, consistency, and compliance with SOPs, policies, specifications, and regulatory guidelines.
- Lead deviation investigations, assess product impact, and document final assessments and lot dispositions for QA Management and client review.
- Enters data into databases supporting root cause analysis (RCA) and CAPA activities.
- Provide oversight of RCA group activities, including organizing meetings, preparing agendas, publishing meeting minutes, and following up on tasks.
- Interface with department management to ensure timely completion of tasks.
- Provide Deviation and CAPA metrics for management reviews.
Training & Compliance Oversight:
- Assist with training employees in deviation and CAPA investigation processes.
- Serve as the QAC Lead Associate in the absence of the QAC Lead Associate.
- Ensure compliance with Good Manufacturing Practices (cGMPs) and other applicable regulations.
Collaboration:
- Work with cross-functional departments to capture appropriate details in investigations and corrective actions.
- Engage in regulatory and client audits by presenting assigned deviations.

Qualifications:

Associate Level:

Education: Associate’s Degree in Biology, Chemistry, or a related field (Bachelor’s degree preferred).
Experience: Minimum of 2 years of relevant experience.
Skills: Knowledge of technical writing, investigations, CAPA systems, and manufacturing processes.
Preferred: Experience in the pharmaceutical or FDA-regulated industry.

Sr. Associate Level:

Education: Associate’s Degree (Bachelor’s degree preferred).
Experience: Minimum 5 years of experience with an Associate’s degree or 2 years of experience with a Bachelor’s degree in a similar role.
Skills: Strong experience with CAPA systems, technical writing, and QA operations. Must be knowledgeable in cGMPs and have experience with regulatory inspections.
Additional Requirements:
- Ability to manage investigations based on product impact.
- Excellent verbal and written communication skills.
- Ability to prioritize tasks and manage conflict effectively.
- Ability to lift 30 pounds unassisted and perform prolonged sitting tasks.

Both Levels:

Direct or supporting aseptic manufacturing experience in the bio/pharma industry is a plus.
Proficiency with Microsoft Word & Excel required.
Sologic Certification preferred.

Shift:

Weekdays, Monday through Friday (08:00 AM – 04:30 PM)

Compensation:

Associate: $30.01 - $40.59 per hour, depending on experience.
Sr. Associate: $67,725 - $102,000 annually, depending on experience.
- Midpoint and above salaries are reserved for employees with longevity and consistent outstanding performance.

Benefits:

Comprehensive benefits package including Medical, Dental, Vision, Flexible Spending, and Health Savings Accounts.
Life, AD&D, Short and Long Term Disability coverage.
401(k) with company match.
Paid Time Off and paid holidays.
Employee Assistance Program.
Optional Benefits: Voluntary Life and AD&D for employee & family, Supplemental Medical coverage (Critical Illness, Hospital Indemnity, and Accident coverage), Pet Insurance, ID Theft Protection, Perk Spot Discount Program.

How to Apply:
To apply, please visit Jubilant HollisterStier Careers, select the Spokane, WA location, and submit your application.

Jubilant HollisterStier is an Equal Opportunity 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.

Contact Information:
If you require assistance applying for this position, please contact our HR Department at:
Email: Human.Resources@jubl.com

EEO Notice of Rights
Equal Employment Opportunity is the Law.

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Qa Compliance Associate/Sr. Associate

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