What are the responsibilities and job description for the Manufacturing Associate II/III/Sr.-1st Shift position at Alkermes?
To inspect the GMP (Good Manufacturing Practices) vials - product and glass vials - for defects. Perform label and packaging activities for the finished product.
KEY DUTIES:
- Inspect vialed product and empty glass for defects
- Perform daily process activities in compliance with standard operating procedures (SOPs)
- Prepare all process-specific and ancillary equipment (i.e., glassware, apparatus) for use in assigned areas.
- Assist in writing and implementing the area’s process documents.
- Operate equipment in compliance with SOPs
- Assure compliance with cGMP requirements (current good manufacturing practices)
- Work non-routine hours as required to maintain production schedule
- Perform label and packaging activities for the finished product.
- Complete and review associated production records and daily trending
- Train new inspectors in accordance with vial inspector certification procedures
- Assist other manufacturing functions (Formulation, Fill, Materials) as required
SKILLS/ABILITIES:
- Organization and interpersonal Skills (Oral, Written, etc.)
- Good Computer and Database Skills
- Comprehensive training focused on current Good Manufacturing Practices (cGMP) in the pharmaceutical industry.
PERSONAL ATTRIBUTES:
- Good math skills
- Self-motivated
- Good visual acuity
- Team Oriented
- Effective organization skills and attention to detail
- Ability to work with minimal supervision
- Ability to work flexible hours
- Ability to work hands-on
PHYSICAL REQUIREMENTS
- Prolonged periods of sitting or standing.
- Periods of repetitive motion
- Walking, squatting, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
- Steel-toe shoes, scrubs, and other PPE equipment must be worn based on the job being performed.
- Employee must be able to pass a vision exam before employment and annually.
Qualifications:
Manufacturing Associate II
Basic Qualifications:
- High School Diploma or equivalent
- 1-3 year of pharmaceutical manufacturing or equivalent experience.
Preferred Qualifications:
- 1 year experience in a sterile pharmaceutical operation
- Associates degree or higher in a science/technical discipline
- Vial or general inspection experience preferred.
Manufacturing Associate III
Basic Qualifications
- High School diploma or equivalent.
- 4-5 years experience in pharmaceutical Manufacturing
Preferred Qualifications
- 2-3 years experience in a sterile pharmaceutical operation
- Associate degree or higher in a science/technical discipline
Sr. Manufacturing Associate I
Required Education and Experience
- High School diploma or equivalent.
- 4-5 years’ experience in pharmaceutical Manufacturing
Preferred Education and Experience
- 2-3 years’ experience in a sterile pharmaceutical operation
- Associates degree or higher in a science/technical discipline
- Training experience
KEY DUTIES:
- Inspect vialed product and empty glass for defects
- Perform daily process activities in compliance with standard operating procedures (SOPs)
- Prepare all process-specific and ancillary equipment (i.e., glassware, apparatus) for use in assigned areas.
- Assist in writing and implementing the area’s process documents.
- Operate equipment in compliance with SOPs
- Assure compliance with cGMP requirements (current good manufacturing practices)
- Work non-routine hours as required to maintain production schedule
- Perform label and packaging activities for the finished product.
- Complete and review associated production records and daily trending
- Train new inspectors in accordance with vial inspector certification procedures
- Assist other manufacturing functions (Formulation, Fill, Materials) as required
SKILLS/ABILITIES:
- Organization and interpersonal Skills (Oral, Written, etc.)
- Good Computer and Database Skills
- Comprehensive training focused on current Good Manufacturing Practices (cGMP) in the pharmaceutical industry.
PERSONAL ATTRIBUTES:
- Good math skills
- Self-motivated
- Good visual acuity
- Team Oriented
- Effective organization skills and attention to detail
- Ability to work with minimal supervision
- Ability to work flexible hours
- Ability to work hands-on
PHYSICAL REQUIREMENTS
- Prolonged periods of sitting or standing.
- Periods of repetitive motion
- Walking, squatting, lifting, pushing and pulling carts, reaching, climbing, and bending may all be required.
- Steel-toe shoes, scrubs, and other PPE equipment must be worn based on the job being performed.
- Employee must be able to pass a vision exam before employment and annually.
Qualifications:
Manufacturing Associate II
Basic Qualifications:
- High School Diploma or equivalent
- 1-3 year of pharmaceutical manufacturing or equivalent experience.
Preferred Qualifications:
- 1 year experience in a sterile pharmaceutical operation
- Associates degree or higher in a science/technical discipline
- Vial or general inspection experience preferred.
Manufacturing Associate III
Basic Qualifications
- High School diploma or equivalent.
- 4-5 years experience in pharmaceutical Manufacturing
Preferred Qualifications
- 2-3 years experience in a sterile pharmaceutical operation
- Associate degree or higher in a science/technical discipline
Sr. Manufacturing Associate I
Required Education and Experience
- High School diploma or equivalent.
- 4-5 years’ experience in pharmaceutical Manufacturing
Preferred Education and Experience
- 2-3 years’ experience in a sterile pharmaceutical operation
- Associates degree or higher in a science/technical discipline
- Training experience
1st Shift Manufacturing Engineer
GE Aerospace -
Vandalia, OH
