Quality Systems and Compliance Contractor 2055321
Location:  Cambridge, MA (Hybrid)
Science:  Small Molecule
Job Overview: This role involves supporting quality systems and compliance functions through reconciling complaints with partners, developing training, supporting document control tasks for audits, and assisting with regulatory inspection preparations.
Primary Job Responsibilities:

• Manage product complaints, including intake, reconciliation, reporting, training development, SOP revision, and archiving.

• Support document control tasks for Vendor and Audit teams.

• Assist with regulatory inspections and provide onsite support; role includes remote and onsite responsibilities.

Primary Job Requirements:

• Skilled in Veeva systems, knowledgeable in Vendor/Audit documentation, with a B.S. in a relevant field and 5+ years in Pharma Quality/Regulatory.

• Experienced in product complaint and adverse event management.

• Proficient in GxP regulations and document control.

About Stratacuity:
Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
PROVEN SCIENTIFIC PLACEMENT™
Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com or 844-463-6178.