"Alerted.org

Our client, one of the largest pharmaceutical companies in USA is looking for a Operations Specialist - II (Associate) to work at Rahway, NJ. Please apply if you have worked in Pharma/Biotech companies under Manufacturing setups with their Vaccines/sold drugs setups under GMP's and SOP's.

**Job Title:** Operation Specialist

**Duration:** 6 months role with a possibility of extension based on performance and budget.

**Location:** 100% onsite role - Rahway, NJ 07065

**Hours:** M-F 8am - 5pm

Candidate should have past experience with:-

+ **Drafting/Authoring docs(SOP’s and protocols) related to process, safety, aseptic techniques, cleaning operations.**

+ **Supporting manufacturing facility.**

+ **Supporting Clinical studies and lab activities.**

+ **Managing inventory system like SAP.**

+ **Supporting formulation teams within lab.**

+ **Developing several process improvements plans.**

+ **Conduct investigation and provide CAPA.**

+ **Supporting R&D projects whenever needed** .

Qualifications:

Position Overview:

The Support Technician is an individual contributor with operational and technical responsibilities.

_This position has multiple roles that include:-_

1. (Supporting Formulation, Laboratory and Experimentation Center (FLEx Center) activities (CQ&V, author/review SOPs, SAP, etc.),

2. Leveraging experience in drug product manufacturing to support daily manufacturing and cleaning operations (development & GMP activities) within the FLEx Center, and

3. Leveraging scientific/technical capabilities to support R&D development program activities as needed. The Support Technician position will flex between roles when necessary to drive program and development needs.

Required Experience and Skills:

+ Education Minimum Requirement: B.S. Degree in Science, Engineering or other technical field.

+ **Required Experience and Skills: Minimum (2-3) years’ experience in a functional area, such as Operations, Technical Operations, Technology, Engineering.**

+ Preferred Experience and Skills: Minimum (2-3) years’ experience in relevant manufacturing or processing (bulk, solid oral dosage, solutions/suspensions, packaging, etc.) with working knowledge of current good manufacturing procedures (cGMP)

Software expertise:

+ MS office, Inventory management system like SAP.

Personality:

+ Detail Oriented

+ Team player

+ Independent

+ Flexible

Responsibilities:

+ Incorporate scientific and technical knowledge to complete assigned tasks.

+ Collaborate with internal stakeholders to drive effective communication and completion of deliverables.

+ Understand priorities from manager/supervisor to ensure task completion.

+ Understand/act on guidance from supervisor where decisions are guided by policies, procedures, and business plan.

+ Identify and help to resolve standard day to day quality, technical, and operational problems.

+ Make decisions guided by policies and standard operating procedures.

+ Compliance: Responsible for sustaining a culture of compliance (Safety, Environment, cGMP).

+ Exercise judgement and decision making to ensure quality product is reliably produced.

+ Utilization of our client's Leadership Behaviors and Ways of Working to promote daily work activities.

+ Keep informed on current policies/procedures and all other FLEx Center communications.

+ Comply with all safety rules and regulations and take prompt corrective action concerning potential safety hazards.

+ Support compiling safety related documentation requirements (e.g. process waste identification/collection)

+ Help to identify root causes of manufacturing issues and implement corrective action.

+ Author/review documentation related to operational procedures and/or reports.

+ Oversee equipment support, cleaning activities, and the review/approval SOPs and technical documents.

+ Technical support for manufacturing and packaging activities.

+ Support equipment and cleaning processes.

+ Equipment administration management.

+ Adaptive to learn new skills or processes (SAP) to drive functionality of the FLEx Center to meet objectives.

If this is a role that interests you and you’d like to learn more, click apply now and a recruiter will be in touch with you to discuss this great opportunity. We look forward to speaking with you!

About ManpowerGroup, Parent Company of:** **Manpower, Experis, Talent Solutions, and Jefferson Wells

_ManpowerGroup® (NYSE: MAN), the leading global workforce solutions company, helps organizations transform in a fast-changing world of work by sourcing, assessing, developing, and managing the talent that enables them to win. We develop innovative solutions for hundreds of thousands of organizations every year, providing them with skilled talent while finding meaningful, sustainable employment for millions of people across a wide range of industries and skills. Our expert family of brands –_ **_Manpower, Experis, Talent Solutions, and Jefferson Wells_** _–_ creates substantial value for candidates and clients across more than 75 countries and territories and has done so for over 70 years. We are recognized consistently for our diversity - as a best place to work for Women, Inclusion, Equality and Disability and in 2022 ManpowerGroup was named one of the World's Most Ethical Companies for the 13th year - all confirming our position as the brand of choice for in-demand talent.

ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.