Associate III Downstream Manufacturing Rotation

Position: Associate III Downstream Manufacturing - 12hr. Rotation Schedule (2/2/3)
This job is with Thermo Fisher Scientific, an inclusive employer and a member of my Gwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.

Work Schedule
12 hr shift/days  Environmental Conditions
Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

Job Description
Operating equipment is used to manufacture products. Weighs, measures and checks raw materials to ensure that batches manufactured contain proper ingredients in proper quantities. Fully trained and proficient at manufacturing drug product injectables in a cleanroom environment and following GMP standards. Autonomously run equipment, pumps, and automated systems and collaborate with team members to ensure it's right the first time and on schedule.

Perform operations in Support Services, Upstream, Downstream, and Fill/Finish work streams following SOPs and Batch records and recommending improvements.

Work Hours:

This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include holidays.  This role is a 1st shift, 7am-7pm shift (2/2/3 Rotation).

Responsibilities
Optimally complete work instructions while following procedures and cGMP regulations. Applications of acquired job skills and company policies and procedures to complete assigned task
Fully trained on all unit operations associated with the department. Works on assignments that are semi-routine in nature but receives instruction on new processes that are accepted practices
Follows established procedures on routine work, requires instructions only on new assignments.
Stays up to date on required job training.
Maintains inventory records of raw materials used in batch manufacturing. Keeps accurate and up-to-date batch records and data sheets on batches in process.
Inspect finished product to assure adherence to specifications such as appearance, foreign substances and packaging or labeling requirements as required
Assist with manufacturing batch records reconciliation.
Complete assigned work tasks on time.
Adhere to SOP’s, Batch Records, and Wok Instructions by living the Quality values every day and holds peers across the site accountable as well.
Support the on-time closure of Nonconformance’s/ CAPAs.
Assist in the completion and identification of PPI initiatives and continuous improvements.
Identify and communicate items requiring customer concern; complete post critical issue decisions.
Accurately records and analyzes batches against standards all processing data gathered from instruments, etc. to ensure operating standards are met.
Make approved adjustments as appropriate to maintain process parameters within designated limits.
Maintain a culture of safety by identification of near misses, safety walkthroughs and assisting with resolution of safety observations.
Ensure chemicals are properly stored and labeled.
90% of time spent on the floor

Education/Experience/Equivalency Requirements:
High School Diploma or Equivalent
Minimum of 2 years’ experience in manufacturing/operations

Knowledge, Skills and Abilities:

Ability to perform aseptic operations. Surface level problem solving skills.
Ability to anticipate system response.
Understand cleanroom concepts.
Ability to follow directions & procedures and work in team environment.
Strong attention to detail and aim to accomplish the job timely, accurately and safely the first time is required, as well as the ability to work closely and effectively in a team environment.
Ability to apply knowledge of Good Manufacturing processes and the knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
Adhere to all Personal Protective Equipment (PPE) requirements used within cGMP manufacturing.

Physical Requirements:

Employee is regularly required to stand; use hands to finger, handle, or feel; reach…