Job Title: QA Specialist

Job Description

The QA Specialist role is responsible for maintaining the License to Operate (LTO) for products and processes manufactured at the facility; including interpretation of internal quality standards and external regulatory requirements for the manufacturing of a biologic combination product. This role provides support and guidance to other functional teams in Operations, QC, and Quality primarily through Quality Documentation activities.

ResponsibilitiesSupport Quality, Compliance, and Operational risks via ownership and continuous improvement of the following business processes:- GxP Documentation Management- Quality Management Review- Annual Product Quality Review- Internal Quality Standard Assessments- Other Compliance Processes as applicableUtilize Lean principles, mindset, and ways of working such as problem-solving, 5S, and visual management.Provide guidance to the cross-functional working team(s) to ensure compliant and timely execution of Quality Documentation tasks such as archiving and logbook preparation.Become actively involved in daily operations when required to meet schedules or to resolve problems.Essential SkillsExperience with inspection, GMP, QA, biology, Quality assurance, Document control, SOP, Quality control, and Batch record management.Professional manner and excellent verbal communication skills.Good judgment skills.Knowledge of packaging operations from Operations/Production or QA experience.Able to work alone for the majority of the shift.Able to stand/walk around the packaging area for 90% of the shift.Additional Skills & QualificationsDiploma; some college preferred.Experience with aseptic techniques.Preferably at least a year or two of GMP experience in a QA inspection or documentation role within a cGMP environment such as manufacturing or lab.Work Environment

The work environment includes working the 1st shift, Tuesday to Friday from 5:45 AM to 4:15 PM. This role is within a large international pharmaceutical company, offering recent college graduates the opportunity to gain GMP experience. Seasonal workers receive a two-week notice before the end of the season to assist in finding the next opportunity. Returning seasonal workers receive a pay increase every year. Several hiring managers were once seasonal workers and were hired full-time. The company provides PPE including lab glasses and boots. The environment is fun and welcoming.

Pay and Benefits

The pay range for this position is $35.38 - $35.38

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

Hiring diverse talent Maintaining an inclusive environment through persistent self-reflection Building a culture of care, engagement, and recognition with clear outcomes Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.