Qa Compliance Associate/ Sr.Associate

Jubilant Pharma

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 (Fri - Sun Nights)
Location: Spokane, WA
Company: Jubilant HollisterStier

Job Description:

Jubilant HollisterStier LLC, part of the Jubilant Pharma family, is a global leader in the manufacture of allergenic extracts, targeted at treating allergies and asthma, as well as contract manufacturing of sterile injectable vials and lyophilized products. We are seeking a QA Compliance Associate/Sr. Associate to support our Deviations, Corrective and Preventive Action (CAPA) program, focusing on root cause analysis (RCA) and vendor complaints/issues, to ensure product compliance and safety.

Key Responsibilities:

Review deviations, investigations, and CAPAs to ensure accuracy, consistency, and compliance with applicable SOPs, policies, and regulations.
Facilitate deviation investigations and resolutions, assess product impact, and provide final assessments for QA Management and client approval.
Enter data into databases supporting RCA and CAPA activities.
Provide oversight of investigational RCA activities, including meeting agendas, minutes, and follow-up on tasks.
Interface with management and team members to ensure task completion on schedule.
Ensure compliance with quality systems, processes, and procedures to maintain product quality and safety.
Assist in implementing corrective actions resulting from deviations, audits, or inspections.
Provide Deviation and CAPA metrics for management review.
Work with departments to ensure proper documentation of investigations or corrective actions.

For Sr. Associate:

Provide training to the Quality Unit and other departments on investigation handling.
Represent QA during regulatory and client audits.
Act as the QAC Lead Associate in the absence of the QAC Lead Associate.
Perform special assignments as directed by the supervisor.

Qualifications:

QA Compliance Associate:

Associate's Degree in Biology, Chemistry, or related field required (5 years of experience can be used in lieu of a degree).
Minimum of 2 years of experience in pharmaceutical or FDA-regulated industries.
Experience with technical writing, investigations, CAPA systems, and quality systems is highly desired.
Knowledge of cGMPs desired.

QA Compliance Sr. Associate:

Associate's Degree in Biology, Chemistry, or related field required. Bachelor's Degree in a science field is preferred.
Minimum of 5 years related experience required with an Associate's Degree. At least 2 years of experience with a Bachelor's degree.
Experience in pharmaceutical or FDA-regulated industries required.
Strong technical writing skills and experience with investigations, CAPA systems, and QC analysis.
Knowledge of cGMPs is required.
Demonstrated strong interpersonal, conflict management, and verbal/written communication skills.
Ability to prioritize investigations based on facility impact and batch release.

For Both Positions:

Direct or supporting aseptic manufacturing experience in the bio/pharma industry desired.
Proficiency in Microsoft Word and Excel required.
Sologic Certification desired.
Ability to lift 30 pounds unassisted.
Prolonged sitting required.
Ability to manage conflict and influence outcomes.

Shift:

Friday – Sunday Nights from 5:00 PM – 5:30 AM (3x12-hour shifts)

Compensation:

QA Compliance Associate: $30.01 - $40.59 per hour
QA Compliance Sr. Associate: $67,725 - $102,000 annually (based on experience)

Benefits:

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
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

Jubilant HollisterStier is an equal opportunity employer, and we encourage all qualified applicants to apply. If you're ready to join a dynamic and rewarding team, we invite you to apply today!

For more details and to apply:
Click Here to Apply

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.

For Assistance:
Human.Resources@jubl.com

Recommended Jobs

Pharma Jobs in India

Gujarat :

Maharashtra :

Haryana :

Andra Pradesh :

Tamil Nadu :

Himachal Pradesh :

Baddi | Solan |

Rajasthan :

Karnataka :

Punjab :

Madhya Pradesh :

Odisha :

Bhubaneswar | Rourkela |

Chhattisgarh :

Bilaspur | Eot Municipality | Raipur |

Uttarakhand :

Delhi :

Delhi | India | New Delhi | PAN-India |

Assam :

Dibrugarh | Diburghar | Guwahati |

West Bengal :

Digha | Kolkata | Mukundapur |

Uttar Pradesh :

Goa :

Goa | Panaji | Verna |

Bihar :

Hajipur | Patna |

Kerala :

Pondicherry (Puducherry) :

Pondicherry (Puducherry) |

Jharkhand :

Ranchi |

Sikkim :

Rangpo |

India :

Siliguri |

Pharma Jobs in United States

Illinois :

Maryland :

Texas :

California :

New York :

New Mexico :

Albuquerque | Farmington | Santa Fe | Tucumcari |

Pennsylvania :

Alaska :

Massachusetts :

Wisconsin :

United states :

Georgia :

Atlanta | Augusta | Rome |

Maine :

Bangor | Brewer |

New Jersey :

Ohio :

LA :

Baton Rouge | Monroe | New Orleans |

Washington :

Oregon :

Wyoming :

Big Piney | Cokeville |

Alabama :

Birmingham |

Virginia :

Blacksburg | Charlottesville | Falls Church | Mechanicsville |

Indiana :

Bloomington | West Lafayette |

Florida :

Idaho :

Boise |

Colorado :

Boulder | Denver | Westminster |

Connecticut :

North Caroline :

Arizona :

South Carolina :

Charleston |

Kansas :

North Carolina :

Concord | Lumberton | North Carolina |

Michigan :

Detroit | Houghton Lake | Macomb | Southfield |

North Dakota :

Dickinson |

Minnesota :

Kentucky :

Edgewood | Ft MItchell | Louisville | Shelbyville |

Arkansas :

Fort Smith |

Kington :

Frank Scottile Blvd |

Missouri :

Fulton | Milan | St. Louis |

United States :

Hawai | kentucky | Sylmar | Woonsocket |

Nebraska :

Hebron | Nebraska City |

Hawaii :

Hilo | Honolulu |

Tennessee :

Knoxville | Memphis | Nashville |

Louisiana :

Lake Charles | Shreveport |

Nevada :

Las Vegas | Tonopah | Tonopsh | Virginia |

New Hampshire :

Lebanon | Macon | Manchester |

Portugal :

Lisbon | Oeiras | Portugal |

WI :

Madison | Wausau |

Republic of Mexico :

Mexico |

northeastern :

New Hampshire |

Oklahoma :

Oklahoma City |

Puerto Rico :

San Juan |

Albama :

Tuscaloosa |

D.C :

Washington |

Delaware :

Wilmington |

Pharma Jobs in Germany

North Rhine Westphalia :

Munich :

Bavaria |

Bavaria :

Brandenburg :

Berlin |

Baden-Wurttemberg :

Hesse :

Darmstadt | Marburg |

Hessen :

Frankfurt | Harveysburg |

Germany :

Germany | GErmany |

Lower Saxony :

Gottingen | Hannover | Leipzig |

Saxony Anhalt :

Halle |

Rotherbaum :

Hamburg |

Rhineland Palatinate :

Ingelheim am Rhein | Mainz |

Schleswig Holstein :

Kiel |

Berlin :

Mitte |

Mecklenburg Vorpommern :

Rostock |

Saarland :

Saarbrucken |

Pharma Jobs in Europe

Switzerland :

Basel | Zurich |

Serbia :

Belgrade | Serbia |

Hungary :

Budapest |

BULGARIA :

Bulgaria | Vedant |

Denmark :

Copenhagen | Denmark |

Europe :

Finland :

Finland |

Istanbul :

Istanbul | Turkey |

Norway :

Norway | NOrway |

Romania :

Romania |

Belgium :

Wavre |

Pharma Jobs in Ireland

Tipperary :

Ballydine |

Cork :

Brinny | Ringaskiddy |

Carlow :

Carlow |

Republic of Ireland :

Cork | Dublin | Limerick | Waterford |

Ulster :

Donegal |

Meath :

Dunboyne |

Dún Laoghaire :

Dún Laoghaire |

Galway :

Galway |

County Dublin :

Swords |

Pharma Jobs in China

Republic of China :

Beijing |

China :

China | Quarry Bay |

Liaoning :

Dalian |

Zhejiang :

Hangzhou |

Tokiyo :

Osaka | Tokyo |

Shanghai Sai :

Shanghai Shi |

Hubei :

Wuhan |

Pharma Jobs in Netherland

Capital of Netherland :

Amsterdam |

North Brabant :

Breda |

Noord Holland :

Haarlem |

South Holland :

Leiden |

Netherlands :

Netherlands |

Pharma Jobs in Australia

Remote Australia :

Arkansas | Remote Australia |

New South Wales :

Ballina | Sydney |

Republic of Western Australia :

Nedlands |

Queensland :

Queensland |

Melbourne :

South Yarra |

Pharma Jobs in United Kingdom

Surrey :

Chessington | Pirbright |

Antrim :

Larne |

Cheshire :

Runcorn |

Hertfordshire :

Welwyn |

Pharma Jobs in England

United Kingdom :

North Yorkshire :

Harrogate |

South Yorkshire :

Sheffield |

Oxfordshire :

Witney |

Pharma Jobs in Canada & Belgium & South America & Greece & New Zealand & Austria & Spain & Philippines & Croatia & Estonia & Vietnam & Italy & Indonesia & Japan & Finland & Korea & Kazakhstan & Thailand & Israel & Remote & Colombia & Tennessee & Romania & Argentina & Egypt & Mexico & United Arab Emirates & Saudi Arabia & malaysia & Ukraine & Peru & France & South Afrcia & Serbia & Czechia & Chile & Bosnia and Herzegovina & Singapore & Bulgaria & Sweden & Taiwan & Poland

Ontario :

Canada :

Canada |

Quebec :

Montreal |

Brussels :

Brussels |

Antwerp :

Heist op den Berg |

Flemish Brabant :

Zaventem |

South America :

Peru | Argentina |

Brazil :

Sao paulo | Brazil |

Attica :

Athens | Koropi |

Greece :

Greece |

North Island :

Auckland |

New Zealand :

New Zealand |

Austria :

Austria |

Vienna :

Vienna |

Catalonia :

Barcelona |

Madrid :

Madrid |

Cebu Province :

Cebu City |

Philippines :

Manila |

Croatia :

Croatia |

Zagreb :

Zagreb |

Estonia :

Tartu | Estonia |

Harju County (Maakond) :

Tallinn |

Hà Nội :

Hà Nội | Hanoi |

Ho Chi Minh :

Ho Chi Minh City |

Italy :

Italy |

Lombardy :

Rho |

Jakarta :

Jakarta |

East Java :

Surabaya |

Japan :

Saitama | Japan |

Tokyo :

Otemachi |

North Ostrobothnia :

Oulu |

Southwest Finland (Varsinais-Suomi) :

Turku |

Remote Korea :

Remote Korea |

Republic of Korea :

Seoul |

Kazakhstan :

Almaty |

Republic of Thailand :

Bangkok |

Israel :

Remote :

Republic of Colombia :

Bogota |

Williamson :

Brentwood |

Bucharest :

Bucharest |

Buenos Aires :

Buenos Aires |

Republic of Egypt :

Cairo |

Mexico :

Ciudad de México | New Mexico |

Dubai :

Dubai |

Makkah :

Kuala Lumpur :

Kuala Lumpur |

Kyiv Oblast :

Kyiv |

Lima Region :

Lima |

France :

Lyon | Paris |

South Africa :

South Africa | Midrand |

Nišava District :

Niš |

Bohemia :

Prague |

Chile :

Santiago |

Bosnia and Herzegovina :

Sarajevo |

Singapore :

Singapore |

Sofia City :

Sofia |

Sweden :

Sweden |

Taipei :

Taipei |

Mazovia :

Warsaw |

Welcome Back

Create Account

Qa Compliance Associate/ Sr.Associate

Job Description

Recommended Jobs

Senior Analyst, Qa

Quality Assurance Area Specialist Iv

Group Leader Quality Assurance - Clinical Qa

Quality Sr Specialist - Qa - Tapi

Project Coordinator (Qa) - Core Labs

Qa Head

Commercial Programs Quality Oversight- Remote

Qa Validation Specialist/Senior Specialist

Specialist, Quality Assurance