This position reports to Weekend Swing (D) shift. This shift schedule is Saturday and Sunday 10:00 AM to 10:00 PM, plus a third day during the week which will be assigned by your supervisor. This shift requires working on all company designated holidays. Due to business need, you may be required to work your designated third day, in addition to the company designated holiday(s).
This position is responsible for supporting all processes in production while strictly adhering to cGMP, environmental health and safety guidelines and any other related regulations which could apply. Under the general direction of the manufacturing lead operator and the overall direction of the supervisor, this position shall be responsible for the hands on execution of all manual activities in the production area and surrounding corridors outside the production area.
Essential Duties and Responsibilities
- Follow all safety rules, SOPs, cGMP, work rules and other company policies and initiatives.
- Support all local manufacturing operations.
- Complete relevant paperwork following GDP/GMP guidelines.
- Perform hands-on execution of manual manufacturing operations. Manual activities include weighing and addition of chemicals, paste suspension, equipment cleaning, post-process room cleaning, small parts cleaning, equipment assembly/disassembly, transfer panel connections and other activities.
- Receive and distribute supplies into the production area as necessary.
- Perform removal of hazardous waste.
- Communicate issues related to safety, quality, compliance and equipment to the manufacturing lead operator and supervisor.
- Participate in the training of team members.
- May perform other duties as assigned.
- Must be able to assist with prioritization of assignments in order to maximize support for the manufacturing production area.
- Must have good communication skills (both verbal and written) and understanding of cGMP regulations in a pharmaceutical manufacturing environment.
- Must be able to read and follow detailed written procedures.
- Good interpersonal skills and be able to work effectively and efficiently in a team environment.
- Knowledge of basic chemical and biological safety procedures.
- Basic computer skills.
Education and/or experience
Requires high school diploma. No experience required.
- Must be able to lift, push, pull and carry up to 50 lbs.
- Must be able to stand for extended periods of time throughout the duration of an 8 or 12 hour shift.
- Must be able to climb ladders and stairs while wearing special gowning.
- May require bending, twisting, reaching, and/or squatting motions to perform certain tasks.
- In general, the position requires a combination of sedentary work and walking around observing conditions in the facility.
- Must be able to work in controlled environments requiring special gowning. Will be required to follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.
- No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.
- Will work around chemicals such as alcohol, acids, buffers and filter aid that may require respiratory protection. Facial hair must be removed if required to wear respirator.
- Will work in a cold, wet environment.
- Must be able to work multiple shifts, including weekends.
- Must be able to work overtime as required. (only for non-exempt positions)
- May be required to work in a confined area.
- Some Clean Room and cool/hot storage conditions.
Location/Region: Los Angeles, CA